TABLE TOP FOR SPECIAL DISCIPLINES

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

ON 23RD NOVEMBER 2023, GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR TABLE COLUMNS - 115002A0 - ALPHAMAQUET OPERATING TABLE COLUMN. AS IT WAS STATED, AFTER TAKING OVER THE TABLE COLUMN, THE USER WANTED TO MOVE THE TRANSPORTER. AT THE SAME TIME, AN ATTEMPT WAS MADE TO SHUT DOWN THE COLUMN USING THE REMOTE CONTROL. THE STAFF ACCIDENTALLY PRESSED THE WRONG BUTTON ON THE REMOTE CONTROL (TILT BUTTON). THE ERROR WAS RECOGNIZED EARLY BY THE USER SO NO PATIENT HARM OCCURRED. THE SITUATION TOOK PLACE WITH AN ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED TILT OF THE TABLE COLUMN THAT COULD LEAD TO THE PATIENT FALL, WAS TO REOCCUR.

Additional Manufacturer Narrative

GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR TABLE TOPS - 115023B0 TABLE TOP FOR SPECIAL DISCIPLINES USED WITH 115002A0 - ALPHAMAQUET OPERATING TABLE COLUMN, 115050BC LEG PLATES (CODED), 114061C0 TRANSPORTER AND 115091P5 IR TRANSMITTER WITH LASER DIODE. AS IT WAS STATED, AFTER TAKING OVER THE TABLE COLUMN, THE USER WANTED TO MOVE THE TRANSPORTER. AT THE SAME TIME, AN ATTEMPT WAS MADE TO SHUT DOWN THE COLUMN USING THE REMOTE CONTROL. THE STAFF ACCIDENTALLY PRESSED THE WRONG BUTTON ON THE REMOTE CONTROL (TILT BUTTON). THE ERROR WAS RECOGNIZED EARLY BY THE USER SO NO PATIENT HARM OCCURRED. THE SITUATION TOOK PLACE WITH AN ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED TILT OF THE TABLE COLUMN THAT COULD LEAD TO THE PATIENT FALL, WAS TO REOCCUR. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT AND, THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS MALFUNCTION OF THE TABLE TOP WAS FOUND, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS NOT UP TO THE SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WAS A SERIOUS INJURY TO A PATIENT WHEN THIS PARTICULAR ISSUE OCCURRED. COMPARING THE NUMBER OF COMPLAINED DEVICES TO THE NUMBER OF THE 115023 TABLE TOPS PLACED ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS (B)(4). COMPARING THE NUMBER OF COMPLAINED DEVICES TO THE NUMBER OF THE 115023 TABLE TOPS, 115002 COLUMNS, 115050 LEG PLATES, 114061 TRANSPORTERS AND 115091 IR REMOTE CONTROLS USED IN THE CONFIGURATION, PLACED ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS (B)(4). THE AFFECTED GETINGE TABLE TOP WAS MANUFACTURED ON 24TH JULY 2001. THE REVIEW OF THE CUSTOMER PRODUCT COMPLAINTS DATABASE REVEALED THAT IN THE PAST THERE WERE NO CUSTOMER PRODUCT COMPLAINTS RELATED TO THE WORN VELCRO. THE CUSTOMER HAS A MAINTENANCE CONTRACT WITH GETINGE. LAST MAINTENANCE WAS CARRIED OUT ON 8TH AUGUST, 2023. THE STAFF ACCIDENTALLY PRESSED THE WRONG BUTTON ON THE REMOTE CONTROL (TILT BUTTON). THE PATIENT WAS NOT SECURED WITH BELTS. IN THE INSTRUCTIONS FOR USE (GA 1150.23 REV. 3, PAGE 4), THE USER IS WARNED THAT UNINTENTIONAL OPERATING TABLE ADJUSTMENTS WITH UNSECURED PATIENTS CAN CAUSE INJURIES TO THE PATIENT. THE PATIENT MUST BE SECURED WITH SUITABLE ATTACHMENTS IN ACCORDANCE WITH THE RELEVANT STIPULATED REQUIREMENTS (E.G. BODY BELT, SIDE SUPPORTS ETC.). IT HAS BECOME EVIDENT THAT THE USER UTILIZED THE TABLE DISREGARDING THE SAFETY NOTE FROM THE IFU. IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT WAS CONCLUDED THAT WEAR OF VELCRO HAS CONTRIBUTED TO THE REPORTABLE ISSUE OCCURRENCE, HOWEVER THE ISSUE WOULD HAVE NOT TAKEN PLACE IF THE USER HAD FOLLOWED THE INSTRUCTIONS FOR USE. IT HAS BEEN RECOMMENDED TO REPLACE THE SEAT PLATE (COMPONENT NUMBER 31129674). THE CUSTOMER HAS NOT DECIDED TO REPAIR THE TABLE TOP. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 09/24/2022. D10 CONCOMITANT PRODUCTS: 115002A0 - ALPHAMAQUET OPERATING TABLE COLUMN, 115050BC LEG PLATES (CODED), 114061C0 TRANSPORTER, 115091P5 IR TRANSMITTER WITH LASER DIODE. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, D1 BRAND NAME, D2 COMMON DEVICE NAME, D4 VERSION OR MODEL #, D4 CATALOG #, D4 SERIAL #, H3A DEVICE EVALUATED BY MANUFACTURER, H3B. DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN AND H4 DEVICE. MANUFACTURE DATE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 23RD NOVEMBER 2023, GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR TABLE COLUMNS 115002A0 - ALPHAMAQUET OPERATING TABLE COLUMN. AS IT WAS STATED, AFTER TAKING OVER THE TABLE COLUMN, THE USER WANTED TO MOVE THE TRANSPORTER. AT THE SAME TIME, AN ATTEMPT WAS MADE TO SHUT DOWN THE COLUMN USING THE REMOTE CONTROL. THE STAFF ACCIDENTALLY PRESSED THE WRONG BUTTON ON THE REMOTE CONTROL (TILT BUTTON). THE ERROR WAS RECOGNIZED EARLY BY THE USER SO NO PATIENT HARM OCCURRED. THE SITUATION TOOK PLACE WITH AN ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED TILT OF THE TABLE COLUMN THAT COULD LEAD TO THE PATIENT FALL, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 23RD NOVEMBER 2023, GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR TABLETOPS - 115023B0 TABLETOP FOR SPECIAL DISCIPLINES USED WITH 115002A0 - ALPHAMAQUET OPERATING TABLE COLUMN, 115050BC LEG PLATES (CODED), 114061C0 TRANSPORTER AND 115091P5 IR TRANSMITTER WITH LASER DIODE. AS IT WAS STATED, AFTER TAKING OVER THE TABLE COLUMN, THE USER WANTED TO MOVE THE TRANSPORTER. AT THE SAME TIME, AN ATTEMPT WAS MADE TO SHUT DOWN THE COLUMN USING THE REMOTE CONTROL. THE STAFF ACCIDENTALLY PRESSED THE WRONG BUTTON ON THE REMOTE CONTROL (TILT BUTTON). THE ERROR WAS RECOGNIZED EARLY BY THE USER SO NO PATIENT HARM OCCURRED. THE SITUATION TOOK PLACE WITH AN ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED TILT OF THE TABLE COLUMN THAT COULD LEAD TO THE PATIENT FALL, WAS TO REOCCUR. PREVIOUS D1 BRAND NAME: ALPHAMAQUET OPERATING TABLE COLUMN: CORRECTED D1 BRAND NAME: TABLETOP FOR SPECIAL DISCIPLINES. PREVIOUS D2 COMMON DEVICE NAME: FQO - TABLE, OPERATING-ROOM, AC-POWERED. CORRECTED D2 COMMON DEVICE NAME: BWN ¿ TABLE AND ATTACHMENTS, OPERATING-ROOM. PREVIOUS D4 VERSION OR MODEL #: 115002A0. CORRECTED D4 VERSION OR MODEL #: 115023B0. PREVIOUS D4 CATALOG #: 115002A0. CORRECTED D4 CATALOG #: 115023B0. PREVIOUS D4 SERIAL #: (B)(4). CORRECTED D4 SERIAL #: (B)(4). PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO. CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES. PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER. CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER. CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A. PREVIOUS H4 DEVICE MANUFACTURE DATE: 07/01/2001. CORRECTED H4 DEVICE MANUFACTURE DATE: 07/24/2001.

Description of Event or Problem

ON 23RD NOVEMBER 2023, GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF OUR TABLE TOPS - 115023B0 TABLE TOP FOR SPECIAL DISCIPLINES USED WITH 115002A0 - ALPHAMAQUET OPERATING TABLE COLUMN, 115050BC LEG PLATES (CODED), 114061C0 TRANSPORTER AND 115091P5 IR TRANSMITTER WITH LASER DIODE. AS IT WAS STATED, AFTER TAKING OVER THE TABLE COLUMN, THE USER WANTED TO MOVE THE TRANSPORTER. AT THE SAME TIME, AN ATTEMPT WAS MADE TO SHUT DOWN THE COLUMN USING THE REMOTE CONTROL. THE STAFF ACCIDENTALLY PRESSED THE WRONG BUTTON ON THE REMOTE CONTROL (TILT BUTTON). THE ERROR WAS RECOGNIZED EARLY BY THE USER SO NO PATIENT HARM OCCURRED. THE SITUATION TOOK PLACE WITH AN ANESTHETIZED PATIENT. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED TILT OF THE TABLE COLUMN THAT COULD LEAD TO THE PATIENT FALL, WAS TO REOCCUR.