ALGO 5 DSP BOX ASSEMBLY

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT#(B)(4). (B)(4) REV D ALGO 5 RISK ANALYSIS, HAZARD 2.1 CAUSE - AC MAINS SHORTED TO CART CHASSIS. AC MAINS FAULT - RESULTS IN AC MAINS VOLTAGE ON CART CHASSIS. EFFECT (HARM) - ELECTRIC SHOCK - THIRD DEGREE BURN, CARDIAC ARREST, IRREGULAR HEART RHYTHM OR POTENTIAL FATALITIES. RESIDUAL RISK - MODERATE. THE HAZARDS IDENTIFIED HAVE RBA RATING OF MEDIUM AND ARE DEEMED BROADLY ACCEPTABLE. THESE RISKS HAVE BEEN REVIEWED TO DETERMINE IF ANY FURTHER CONTROL MEASURES MAY BE IMPLEMENTED SO AS TO FURTHER REDUCE THE RISK AS FAR AS POSSIBLE. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE.

Description of Event or Problem

SITE SUPERVISOR CALLED TO REPORT THAT ONE OF HER SCREENERS, NOTICED THAT THE ALGO WOULD NOT TURN ON. THE ALGO IS MOVED FROM ROOM TO ROOM AND THE CORDS SOMETIMES BECOME LOOSE DUE TO THE LOSS OF POWER, SHE REACHED UNDERNEATH THE GREEN CART BASE TO WIGGLE AND RECONNECT THE POWER CORDS GOING INTO THE POWER TRANSFORMER AND ENDED UP GETTING SHOCKED. THERE WAS NO SMOKE AND SHE DID NOT SEE THE SPARK BUT SHE FELT IT AND BECAME STARTLED AND THEN JUMPED BACK. AFTER GETTING SHOCKED SHE NOTICED THAT ONE OF THE POWER CORDS HAVE EXPOSED WIRES. SHE STATED HOW THE AREA WHERE THE POWER CORDS AND EXPOSED WIRING ARE LOCATED ARE HOT AND HOT TO THE TOUCH AND HOT IN THE AREA WHERE THE POWER CORDS ARE GOING INTO THE TRANSFORMER ADVISED THAT THE CALLER UNPLUG THE UNIT FROM THE WALL AND DISCONTINUE USING THE ALGO UNTIL FIELD ENGINEER COULD GO OUT AND INSPECT THE AREA. INQUIRED IF THE SCREENER IS OK AND CUSTOMER STATED YES. INQUIRED IF THE SCREENER HAD TO RECEIVE MEDICAL ATTENTION AS A RESULT AND CUSTOMER STATED NO.

Description of Event or Problem

SITE SUPERVISOR CALLED TO REPORT THAT ONE OF HER SCREENERS, NOTICED THAT THE ALGO WOULD NOT TURN ON. THE ALGO IS MOVED FROM ROOM TO ROOM AND THE CORDS SOMETIMES BECOME LOOSE DUE TO THE LOSS OF POWER, SHE REACHED UNDERNEATH THE GREEN CART BASE TO WIGGLE AND RECONNECT THE POWER CORDS GOING INTO THE POWER TRANSFORMER AND ENDED UP GETTING SHOCKED. THERE WAS NO SMOKE AND SHE DID NOT SEE THE SPARK BUT SHE FELT IT AND BECAME STARTLED AND THEN JUMPED BACK. AFTER GETTING SHOCKED SHE NOTICED THAT ONE OF THE POWER CORDS HAVE EXPOSED WIRES. SHE STATED HOW THE AREA WHERE THE POWER CORDS AND EXPOSED WIRING ARE LOCATED ARE HOT AND HOT TO THE TOUCH AND HOT IN THE AREA WHERE THE POWER CORDS ARE GOING INTO THE TRANSFORMER ADVISED THAT THE CALLER UNPLUG THE UNIT FROM THE WALL AND DISCONTINUE USING THE ALGO UNTIL FIELD ENGINEER COULD GO OUT AND INSPECT THE AREA. INQUIRED IF THE SCREENER IS OK AND CUSTOMER STATED YES. INQUIRED IF THE SCREENER HAD TO RECEIVE MEDICAL ATTENTION AS A RESULT AND CUSTOMER STATED NO.

Additional Manufacturer Narrative

FOLLOW ON REPORT REF NATUS COMPLAINT# (B)(4). INITIALLY, IT WAS THOUGHT THE DAMAGED POWER CORD FROM THE POWER INLET MODULE WAS THE CAUSE FOR THE SHOCK. FURTHER INSPECTION DISCOVERED THE DAMAGED POWER SUPPLY WAS THE ACTUAL CAUSE. THE SERVICE TECHNICIAN FOUND A DAMAGED PANEL PC POWER SUPPLY CAUSED BY A SCREW PUNCTURING THE CASING THIS WAS DETERMINED TO BE THE CAUSE OF THE ELECTRICAL SHOCK, BECAUSE OF THE ELECTRICAL CONTACT MADE BETWEEN THE POWER SUPPLY AND THE CART COLUMN VIA THE SET SCREW. NATUS ENGINEERING CONFIRMS THAT HE CUSTOMER ASSEMBLES THE ALGO 5 USING THE CART BASE, CART COLUMN, PC PANEL, AND OTHER ITEMS. NATUS ENGINEERING ALSO CONFIRMS THAT THE ASSEMBLY INSTRUCTIONS INCLUDE A CAUTION ABOUT THE POWER CORDS AND CABLES RUBBING ON THE WHEELS. DEVICE HISTORY REVIEWED AND NO ABNORMALITIES FOUND. (B)(4) REV D ALGO 5 RISK ANALYSIS, HAZARD 2.1 CAUSE - AC MAINS SHORTED TO CART CHASSIS. AC MAINS FAULT - RESULTS IN AC MAINS VOLTAGE ON CART CHASSIS. EFFECT (HARM) - ELECTRIC SHOCK - THIRD DEGREE BURN, CARDIAC ARREST, IRREGULAR HEART RHYTHM OR POTENTIAL FATALITIES. RESIDUAL RISK - MODERATE. THE HAZARDS IDENTIFIED HAVE RBA RATING OF MEDIUM AND ARE DEEMED BROADLY ACCEPTABLE. THESE RISKS HAVE BEEN REVIEWED TO DETERMINE IF ANY FURTHER CONTROL MEASURES MAY BE IMPLEMENTED SO AS TO FURTHER REDUCE THE RISK AS FAR AS POSSIBLE. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE.