BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAN SPRAY KIT

    MDR report key: 5806569 · Received July 19, 2016

    Report

    Report Number
    0001526350-2016-00077
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 29, 2016
    Report Date
    August 1, 2016
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED FOR PART NUMBER 00-5150-475-01, LOT 63302699. THIS DEVICE WAS MANUFACTURED AND PLACED INTO INVENTORY ON APR 19, 2016. THERE WERE NO RELATED NON-CONFORMANCES, REQUESTS FOR DEVIATIONS, ENGINEERING CHANGE NOTICES OR OTHER SPONTANEOUS ANOMALIES REPORTED. (B)(6) ¿AA¿ BATTERIES PART NUMBER 06-0013-050-63 FROM LOT NUMBER 80718344 WERE USED IN THE ASSEMBLY OF THE REFERENCED PULSAVACS. THESE BATTERIES WERE CERTIFIED BY THE SUPPLIER AND PLACED INTO ZIMMER SURGICAL INVENTORY ON JAN 28, 2015. THE SHELF LIFE FOR THIS LOT WAS THROUGH 12-2026. NO NON-CONFORMANCES WERE DISCOVERED FOR BATTERIES FROM THIS LOT IN INCOMING INSPECTION OR FROM THE ASSEMBLY/TEST AREA RELEVANT TO THIS COMPLAINT. ON AUG 1, 2016 A SINGLE BATTERY PACK WAS RETURNED AGAINST THIS COMPLAINT NUMBER. THE GREY ELECTRICAL CABLE HAD BEEN SEVERED AND THE BATTERIES HAD A CATASTROPHIC ELECTRICAL SHORT RESULTING IN THE EXPULSION OF SEVERAL ANODES. THE BATTERY PACK WAS THE ONLY ITEM RETURNED. FUNCTIONAL TESTING OF THE BATTERY PACK AND/OR BATTERIES WAS NOT POSSIBLE DUE TO THE ANODE EXPULSIONS. THE CUSTOMERS REPORTED EVENT WAS THAT AFTER SURGERY, ELECTRICAL CABLE FROM THE BATTERY PACK WAS CUT AWAY AND THE BATTERY PACK STARTED HEAT AND TO SMOKE. THE INFORMATION PROVIDED AND THE CONDITION OF THE BATTERY PACK CONFIRMS THE CUSTOMERS REPORTED EVENT. THE INSTRUCTIONS FOR USE LIST SEVERAL SITUATIONS THAT CAN CAUSE A MAJOR ELECTRICAL SHORT IN THE BATTERY PACK. HISTORICALLY THOUGH, THE MOST PREVALENT CAUSE FOR THE BATTERY PACK EXPLODING IS DUE TO SEVERING THE ELECTRICAL WIRE FROM THE BATTERY PACK TO THE HAND-PIECE. CUTTING THE WIRE WITH THE BATTERIES STILL IN PLACE CAN CAUSE A CATASTROPHIC ELECTRICAL SHORT INITIATING ANODE EXPULSION OF THE BATTERIES. THE CAUSE FOR THIS INCIDENT IS IMPROPER DISPOSAL OF THE DEVICE IN CONTRADICTION OF THE IFU WARNINGS BY THE CUSTOMER. THE DEVICE INSTRUCTIONS FOR USE AND THE LABELING ON THE TYVEK LID WARN THAT CUTTING THE BATTERY PACK CABLE COULD LEAD TO SHOCK, EXCESSIVE HEAT AND/OR SPARKS AND COULD RESULT IN FIRE OR PERSONAL INJURY. THE BATTERIES SHOULD BE PHYSICALLY REMOVED FROM THE BATTERY PACK, CARE SHOULD BE TAKEN AND PERSONAL SAFETY EQUIPMENT SHOULD BE WORN. THE INSTRUCTIONS FOR USE EXPLICITLY STATES: WARNINGS: EXPLOSION HAZARD; DO NOT USE IN PRESENCE OF FLAMMABLE ANESTHETICS OR GASES; DO NOT SUBMERGE HANDLE IN LIQUID AS THIS MAY COMPROMISE THE EFFICIENCY OF THE PUMP OR ALTER THE PH OF THE LIQUID; DO NOT CUT THE BATTERY PACK CABLE. CUTTING THROUGH THE BATTERY PACK CABLE COULD LEAD TO SHOCK, EXCESSIVE HEAT AND/OR SPARKS, AND COULD RESULT IN FIRE AND/OR PERSONAL INJURY; DO NOT SUBMERGE THE BATTERY PACK IN LIQUID. ADDITIONALLY, THE (B)(6) LID FOR THE INDIVIDUAL PULSAVACS DEVICES STATES: WARNING: EXPLOSION HAZARD. DO NOT USE IN PRESENCE OF FLAMMABLE ANESTHETICS OR GASES. DO NOT SUBMERGE IN LIQUID AS THIS MAY COMPROMISE THE EFFICIENCY OF THE PUMP OR ALTER THE PH OF THE LIQUID. DO NOT CUT THE BATTERY PACK CABLE. CUTTING THROUGH THE BATTERY PACK CABLE COULD LEAD TO SHOCK, EXCESSIVE HEAT AND/OR SPARKS, AND COULD RESULT IN FIRE AND/OR PERSONAL INJURY. DO NO SUBMERGE THE BATTERY PACK IN LIQUID. USE CAUTION WHEN REMOVING BATTERIES. THE BATTERY PACK CONTAINS ALKALINE BATTERIES. EXPOSURE TO THE CONTENTS OF AN OPEN OR LEAKING BATTERY OR THEIR COMBUSTION PRODUCTS COULD BE HARMFUL. AVOID SKIN AND EYE CONTACT. USE NEOPRENE OR NATURAL RUBBER GLOVES AND SAFETY GLASSES WITH SIDE SHIELDS WHEN HANDLING BATTERIES. RECOMMENDED ACTIONS: WITH THE INITIATION OF THE CAPA, NO ADDITIONAL INTERNAL ZIMMER ACTIONS ARE WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE BATTERY PACK HAD HEAT AFTER THE SURGERY. THE CUSTOMER CUT THAT CABLE AFTER USING, THEN THE BATTERY PACK HEATED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458575 FAN SPRAY KIT FAN SPRAY KIT FQH ZIMMER SURGICAL, INC. N/A 63302699

    Patients

    Seq Age Sex Outcome Treatment
    1