AMBU AVIEW 2 ADVANCE

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO THE MANUFACTURER 23RD OF OCTOBER 2024. THE INVESTIGATION OF THE DEVICE HAS BEEN INITIATED AND IS STILL ONGOING. THE DEVICE WAS DISASSEMBLED AND INVESTIGATED TO ESTABLISH THE SOURCE AND POSSIBLE CAUSE OF THE REPORTED FIRE. IT WAS SPECIFIED IN THE INTERNAL INCIDENT REPORT THAT THE DEVICE WAS NOT DROPPED IN THE PERIOD IMMEDIATELY BEFORE THE INCIDENT. HOWEVER, THE DEVICE SCREEN WAS OBSERVED TO HAVE A LOT OF DAMAGES ON THE SCREEN THAT POINTED TO THE UNIT BEING ABUSED AND POSSIBLY DROPPED AT AN EARLIER POINT IN TIME. SOOT MARKS WAS OBSERVED ON THE INSIDE OF THE CASING, HOWEVER NO CORRESPONDING SCORCH MARKS, SOOT, MELTED COMPONENTS OR OTHER SIGNS OF FIRE WAS TO BE FOUND ON THE MOTHERBOARD. THE INVESTIGATION INDICATES THAT THE FIRE WAS ON A QUITE LIMITED SCALE AND WAS EXTINGUISHED QUICKLY. SINCE THE INVESTIGATION SHOWED THAT THE BATTERY, BATTERY CONNECTOR, BATTERY WIRING AND BATTERY MANAGEMENT SYSTEM ARE ALL INTACT WE HAVE RULED OUT BATTERY FIRES AND BATTERY SHORT-CIRCUIT AS THE CAUSE OF THE FIRE. SIMILARLY, SINCE ALL THE COMPONENTS ON THE MOTHERBOARD ARE INTACT, WE HAVE ALSO RULED OUT ELECTRICAL FIRE AS THE CAUSE. HENCE, WE HAVE RULED OUT THE PRIMARY SOURCES OF ENERGY WITHIN THE DEVICE AS THE CAUSES FOR THE FIRE. WE THEREFORE SUSPECT THAT THE CAUSE IS SOMEHOW EXTERNAL TO THE SYSTEM, BUT WE DO NOT CURRENTLY HAVE A CLEAR HYPOTHESIS AND CANNOT CONCLUDE ON THE ROOT CAUSE YET. FURTHER INVESTIGATION OF THE COMBUSTION SITE IS NEEDED. THE DEVICE WILL NOW BE FURTHER INVESTIGATED AT THE HEAD QUARTER IN DENMARK. A FOLLOW-UP REPORT/FINAL REPORT WILL BE SUBMITTED WHEN MORE INVESTIGATIONS RESULTS ARE AVAILABLE OR WHEN THE INVESTIGATION HAS BEEN FINALIZED.

Description of Event or Problem

DURING A TRAINING COURSE AT A HOSPITAL, IT WAS NOTICED THAT THE DISPLAYING UNIT OVERHEATED WITH FLAMES AT THE BACK OF THE MONITOR. IT WAS CONFIRMED THAT NO ONE WAS HARMED BY THE INCIDENT AND NO DAMAGE WAS CAUSED TO THE ENVIRONMENT. NO MARKS WAS VISIBLE AT THE BACK OF THE MONITOR AFTER THE INCIDENT, HOWEVER A SMELL OF BURNING WAS NOTICED.

Additional Manufacturer Narrative

INITIAL REPORT: 13 NOV 2024. THE DEVICE WAS RETURNED TO THE MANUFACTURER 23RD OF OCTOBER 2024. THE INVESTIGATION OF THE DEVICE HAS BEEN INITIATED AND IS STILL ONGOING. THE DEVICE WAS DISASSEMBLED AND INVESTIGATED TO ESTABLISH THE SOURCE AND POSSIBLE CAUSE OF THE REPORTED FIRE. IT WAS SPECIFIED IN THE INTERNAL INCIDENT REPORT THAT THE DEVICE WAS NOT DROPPED IN THE PERIOD IMMEDIATELY BEFORE THE INCIDENT. HOWEVER, THE DEVICE SCREEN WAS OBSERVED TO HAVE A LOT OF DAMAGES ON THE SCREEN THAT POINTED TO THE UNIT BEING ABUSED AND POSSIBLY DROPPED AT AN EARLIER POINT IN TIME. SOOT MARKS WAS OBSERVED ON THE INSIDE OF THE CASING, HOWEVER NO CORRESPONDING SCORCH MARKS, SOOT, MELTED COMPONENTS OR OTHER SIGNS OF FIRE WAS TO BE FOUND ON THE MOTHERBOARD. THE INVESTIGATION INDICATES THAT THE FIRE WAS ON A QUITE LIMITED SCALE AND WAS EXTINGUISHED QUICKLY. SINCE THE INVESTIGATION SHOWED THAT THE BATTERY, BATTERY CONNECTOR, BATTERY WIRING AND BATTERY MANAGEMENT SYSTEM ARE ALL INTACT WE HAVE RULED OUT BATTERY FIRES AND BATTERY SHORT-CIRCUIT AS THE CAUSE OF THE FIRE. SIMILARLY, SINCE ALL THE COMPONENTS ON THE MOTHERBOARD ARE INTACT, WE HAVE ALSO RULED OUT ELECTRICAL FIRE AS THE CAUSE. HENCE, WE HAVE RULED OUT THE PRIMARY SOURCES OF ENERGY WITHIN THE DEVICE AS THE CAUSES FOR THE FIRE. WE THEREFORE SUSPECT THAT THE CAUSE IS SOMEHOW EXTERNAL TO THE SYSTEM, BUT WE DO NOT CURRENTLY HAVE A CLEAR HYPOTHESIS AND CANNOT CONCLUDE ON THE ROOT CAUSE YET. FURTHER INVESTIGATION OF THE COMBUSTION SITE IS NEEDED. THE DEVICE WILL NOW BE FURTHER INVESTIGATED AT THE HEAD QUARTER IN DENMARK. A FOLLOW-UP REPORT/FINAL REPORT WILL BE SUBMITTED WHEN MORE INVESTIGATIONS RESULTS ARE AVAILABLE OR WHEN THE INVESTIGATION HAS BEEN FINALIZED. FOLLOW-UP REPORT: 16 DEC 2024. FURTHER INVESTIGATION AT HQ IN BALLERUP, DENMARK. THE DEVICE WAS DISASSEMBLED AND INVESTIGATED AT THE BALLERUP SITE. THE VESA BACKPLATE HAD SOOT MARKS THEREBY SHOWING SIGNS OF FIRE. THE ANALYSIS OF IGNITION ENERGY SOURCE IDENTIFIED 3 ABNORMALITIES DIRECTLY RELATED TO OR IMMEDIATELY ADJACENT TO THE VESA INTERFACE. 1. THE BURNED PLASTIC AND SCORCH MARKS NEXT TO VESA BACKPLATE. 2. THE DENT IN THE BATTERY UNDER THE VESA SCREW HOLE. 3. THE LONGER SCREWS IN THE VESA BACKPLATE. IT IS THEREFORE SPECULATED THAT THE DENTED BATTERY CELL ACTED AS THE SOURCE OF ENERGY AND SOMEHOW TRANSFERRED THAT ELECTRICAL ENERGY VIA THE SCREWS AND VESA BACKPLATE INTO THE ORIGIN OF THE FIRE. HOWEVER, IT HAS NOT BEEN POSSIBLE TO DEVICE A CONCRETE SCENARIO THAT SHOULD RESULT IN THE CURRENT PATH FROM DENTED BATTERY TO IGNITION OF CASING MATERIAL WITHOUT DAMAGING BATTERY CELLS, BATTERY FUSE, BATTERY MANAGEMENT SYSTEM, BATTERY WIRING OR ANY OTHER PART OF THE ELECTRONICS OF THE DEVICE., WHICH RULES OUT BATTERY FIRE. SIMILARLY ALL THE COMPONENTS ON THE MOTHERBOARD ARE INTACT RULING OUT ELECTRICAL FIRE AS THE ORIGIN. WE CONCLUDED THAT THE FIRE ORIGINATED IN THE AREAS OF THE CASING NEXT TO THE VESA INTERFACE SINCE IT LIES AT THE CENTRE OF THE SOOT ACCUMULATION, AND IT IS THE ONLY AREA WITH CLEAR SIGNS OF THERMAL DAMAGE. AFTER HAVING ESTABLISHED THE ORIGIN OF THE FIRE IT WAS CONSIDERED WHAT SOURCE OF ENERGY COULD HAVE CAUSED THE IGNITION OF THE CASING MATERIAL IN THAT AREA. BASED ON THE LACK OF DAMAGE TO THE ELECTRONICS ON THE MOTHERBOARD WE RULED OUT MAINS CURRENT AS THE SOURCE OF IGNITION ENERGY. WE SPECULATED THAT THE SOURCE IGNITION ENERGY COULD BE EITHER THE BATTERY OR SOME EXTERNAL CONNECTED OR COUPLED DEVICE. WE WERE NOT ABLE TO DEVISE ANY PLAUSIBLE SCENARIO FOR EITHER, BUT WE ARE ALSO UNABLE TO COMPLETELY RULE THEM OUT. WE THEREFORE CONCLUDE THAT THERE IS NOT SUFFICIENT EVIDENCE TO IDENTIFY THE CAUSE OF THE FIRE. THE INVESTIGATION RESULTS FOUND EVIDENCE OF THE REPORTED FIRE AND DEMONSTRATED THAT THE ORIGIN OF THE FIRE WAS UNRELATED TO THE COMBUSTION OF THE BATTERY OR MOTHERBOARD COMPONENTS. THE INVESTIGATION ALSO RULED OUT ALL KNOWN CAUSES OF THAT FIRE, BUT DESPITE IN-DEPTH INVESTIGATION OF THE COMBUSTION SITE IT HAS NOT BEEN POSSIBLE TO IDENTIFY THE ROOT CAUSE SINCE THE SOURCE OF IGNITION ENERGY COULD NOT BE DETERMINED. B3: DATE OF EVENT: INFORMATION WAS CORRECTED FROM 'BLANK' TO '10/15-2024.' E6: INITIAL REPORTER ALSO SEND REPORT TO FDA. INFORMATION WAS CORRECTED FROM 'YES' TO 'NO'. G3: INFORMATION RECEIVED BY MANUFACTURER. DATE WAS MISTAKENLY WRITTEN INCORRECTLY. IT HAS NOW BEEN CORRECTED TO FROM 10/23-2024 TO 10/15- 2024. H6: ADVERSE EVENT PROBLEM. INVESTIGATION FINDINGS C WAS CORRECT FROM 213 TO 4256. INVESTIGATION CONCLUSIONS D WAS UPDATED FROM NO CODE TO 44.

Description of Event or Problem

DURING A TRAINING COURSE AT A HOSPITAL, IT WAS NOTICED THAT THE DISPLAYING UNIT OVERHEATED WITH FLAMES AT THE BACK OF THE MONITOR. IT WAS CONFIRMED THAT NO ONE WAS HARMED BY THE INCIDENT AND NO DAMAGE WAS CAUSED TO THE ENVIRONMENT. NO MARKS WAS VISIBLE AT THE BACK OF THE MONITOR AFTER THE INCIDENT, HOWEVER A SMELL OF BURNING WAS NOTICED.

Additional Manufacturer Narrative

INITIAL REPORT: 13 NOV 2024. THE DEVICE WAS RETURNED TO THE MANUFACTURER 23RD OF OCTOBER 2024. THE INVESTIGATION OF THE DEVICE HAS BEEN INITIATED AND IS STILL ONGOING. THE DEVICE WAS DISASSEMBLED AND INVESTIGATED TO ESTABLISH THE SOURCE AND POSSIBLE CAUSE OF THE REPORTED FIRE. IT WAS SPECIFIED IN THE INTERNAL INCIDENT REPORT THAT THE DEVICE WAS NOT DROPPED IN THE PERIOD IMMEDIATELY BEFORE THE INCIDENT. HOWEVER, THE DEVICE SCREEN WAS OBSERVED TO HAVE A LOT OF DAMAGES ON THE SCREEN THAT POINTED TO THE UNIT BEING ABUSED AND POSSIBLY DROPPED AT AN EARLIER POINT IN TIME. SOOT MARKS WAS OBSERVED ON THE INSIDE OF THE CASING, HOWEVER NO CORRESPONDING SCORCH MARKS, SOOT, MELTED COMPONENTS OR OTHER SIGNS OF FIRE WAS TO BE FOUND ON THE MOTHERBOARD. THE INVESTIGATION INDICATES THAT THE FIRE WAS ON A QUITE LIMITED SCALE AND WAS EXTINGUISHED QUICKLY. SINCE THE INVESTIGATION SHOWED THAT THE BATTERY, BATTERY CONNECTOR, BATTERY WIRING AND BATTERY MANAGEMENT SYSTEM ARE ALL INTACT WE HAVE RULED OUT BATTERY FIRES AND BATTERY SHORT-CIRCUIT AS THE CAUSE OF THE FIRE. SIMILARLY, SINCE ALL THE COMPONENTS ON THE MOTHERBOARD ARE INTACT, WE HAVE ALSO RULED OUT ELECTRICAL FIRE AS THE CAUSE. HENCE, WE HAVE RULED OUT THE PRIMARY SOURCES OF ENERGY WITHIN THE DEVICE AS THE CAUSES FOR THE FIRE. WE THEREFORE SUSPECT THAT THE CAUSE IS SOMEHOW EXTERNAL TO THE SYSTEM, BUT WE DO NOT CURRENTLY HAVE A CLEAR HYPOTHESIS AND CANNOT CONCLUDE ON THE ROOT CAUSE YET. FURTHER INVESTIGATION OF THE COMBUSTION SITE IS NEEDED. THE DEVICE WILL NOW BE FURTHER INVESTIGATED AT THE HEAD QUARTER IN DENMARK. A FOLLOW-UP REPORT/FINAL REPORT WILL BE SUBMITTED WHEN MORE INVESTIGATIONS RESULTS ARE AVAILABLE OR WHEN THE INVESTIGATION HAS BEEN FINALIZED. 1ST FOLLOW-UP REPORT: 16 DEC 2024. FURTHER INVESTIGATION AT HQ IN (B)(6), DENMARK THE DEVICE WAS DISASSEMBLED AND INVESTIGATED AT THE BALLERUP SITE. THE VESA BACKPLATE HAD SOOT MARKS THEREBY SHOWING SIGNS OF FIRE. THE ANALYSIS OF IGNITION ENERGY SOURCE IDENTIFIED 3 ABNORMALITIES DIRECTLY RELATED TO OR IMMEDIATELY ADJACENT TO THE VESA INTERFACE. 1. THE BURNED PLASTIC AND SCORCH MARKS NEXT TO VESA BACKPLATE 2. THE DENT IN THE BATTERY UNDER THE VESA SCREW HOLE 3. THE LONGER SCREWS IN THE VESA BACKPLATE IT IS THEREFORE SPECULATED THAT THE DENTED BATTERY CELL ACTED AS THE SOURCE OF ENERGY AND SOMEHOW TRANSFERRED THAT ELECTRICAL ENERGY VIA THE SCREWS AND VESA BACKPLATE INTO THE ORIGIN OF THE FIRE. HOWEVER, IT HAS NOT BEEN POSSIBLE TO DEVICE A CONCRETE SCENARIO THAT SHOULD RESULT IN THE CURRENT PATH FROM DENTED BATTERY TO IGNITION OF CASING MATERIAL WITHOUT DAMAGING BATTERY CELLS, BATTERY FUSE, BATTERY MANAGEMENT SYSTEM, BATTERY WIRING OR ANY OTHER PART OF THE ELECTRONICS OF THE DEVICE., WHICH RULES OUT BATTERY FIRE. SIMILARLY ALL THE COMPONENTS ON THE MOTHERBOARD ARE INTACT RULING OUT ELECTRICAL FIRE AS THE ORIGIN. WE CONCLUDED THAT THE FIRE ORIGINATED IN THE AREAS OF THE CASING NEXT TO THE VESA INTERFACE SINCE IT LIES AT THE CENTRE OF THE SOOT ACCUMULATION, AND IT IS THE ONLY AREA WITH CLEAR SIGNS OF THERMAL DAMAGE. AFTER HAVING ESTABLISHED THE ORIGIN OF THE FIRE IT WAS CONSIDERED WHAT SOURCE OF ENERGY COULD HAVE CAUSED THE IGNITION OF THE CASING MATERIAL IN THAT AREA. BASED ON THE LACK OF DAMAGE TO THE ELECTRONICS ON THE MOTHERBOARD WE RULED OUT MAINS CURRENT AS THE SOURCE OF IGNITION ENERGY. WE SPECULATED THAT THE SOURCE IGNITION ENERGY COULD BE EITHER THE BATTERY OR SOME EXTERNAL CONNECTED OR COUPLED DEVICE. WE WERE NOT ABLE TO DEVISE ANY PLAUSIBLE SCENARIO FOR EITHER, BUT WE ARE ALSO UNABLE TO COMPLETELY RULE THEM OUT. WE THEREFORE CONCLUDE THAT THERE IS NOT SUFFICIENT EVIDENCE TO IDENTIFY THE CAUSE OF THE FIRE. THE INVESTIGATION RESULTS FOUND EVIDENCE OF THE REPORTED FIRE AND DEMONSTRATED THAT THE ORIGIN OF THE FIRE WAS UNRELATED TO THE COMBUSTION OF THE BATTERY OR MOTHERBOARD COMPONENTS. THE INVESTIGATION ALSO RULED OUT ALL KNOWN CAUSES OF THAT FIRE, BUT DESPITE IN-DEPTH INVESTIGATION OF THE COMBUSTION SITE IT HAS NOT BEEN POSSIBLE TO IDENTIFY THE ROOT CAUSE SINCE THE SOURCE OF IGNITION ENERGY COULD NOT BE DETERMINED. B3: DATE OF EVENT INFORMATION WAS CORRECTED FROM 'BLANK' TO '10/15-2024'. E6: INITIAL REPORTER ALSO SEND REPORT TO FDA INFORMATION WAS CORRECTED FROM 'YES' TO 'NO'. G3: INFORMATION RECEIVED BY MANUFACTURER DATE WAS MISTAKENLY WRITTEN INCORRECTLY. IT HAS NOW BEEN CORRECTED TO FROM 10/23-2024 TO 10/15- 2024. H6: ADVERSE EVENT PROBLEM INVESTIGATION FINDINGS C WAS CORRECT FROM 213 TO 4256. INVESTIGATION CONCLUSIONS D WAS UPDATED FROM NO CODE TO 44. H10: RELATED REPORT NUMBER INFORMATION WAS CORRECTED FROM 'BLANK' TO '1220828-2024-00019'. 2ND FOLLOW-UP REPORT: 18 DEC 2024. H10: RELATED REPORT NUMBER INFORMATION WAS CORRECTED FROM '1220828-2024-00019' TO '1220828-2024-00020'.

Description of Event or Problem

DURING A TRAINING COURSE AT A HOSPITAL, IT WAS NOTICED THAT THE DISPLAYING UNIT OVERHEATED WITH FLAMES AT THE BACK OF THE MONITOR. IT WAS CONFIRMED THAT NO ONE WAS HARMED BY THE INCIDENT AND NO DAMAGE WAS CAUSED TO THE ENVIRONMENT. NO MARKS WAS VISIBLE AT THE BACK OF THE MONITOR AFTER THE INCIDENT; HOWEVER, A SMELL OF BURNING WAS NOTICED.