BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FAN SPRAY KIT

    MDR report key: 5820315 · Received July 25, 2016

    Report

    Report Number
    0001526350-2016-00082
    Event Type
    Malfunction
    Date Received
    July 25, 2016
    Date of Event
    June 29, 2016
    Report Date
    September 22, 2016
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    FQH
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORDS (DHR) REVIEW WAS PERFORMED FOR PART NUMBER 00-5150-475-01, LOT 63177784. THIS DEVICE WAS MANUFACTURED AND PLACED INTO INVENTORY ON JULY 13, 2015. THERE WERE NO RELATED NON-CONFORMANCES, REQUEST FOR DEVIATIONS (RFDS) OR OTHER ISSUES WITH THIS PRODUCTION LOT. (B)(6) ¿AA¿ BATTERIES PART NUMBER 06-0013-050-63 FROM LOT NUMBER 80698408 WERE USED IN THE ASSEMBLY OF THE REFERENCED PULSAVACS. THESE BATTERIES WERE CERTIFIED BY THE SUPPLIER AND PLACED INTO ZIMMER SURGICAL INVENTORY ON AUGUST 14, 2015. THE SHELF LIFE FOR THIS LOT IS THROUGH DEC 2025. NO RELEVANT NON-CONFORMANCES WERE DISCOVERED FOR BATTERIES FROM THIS LOT IN INCOMING INSPECTION OR FROM THE ASSEMBLY/TEST AREA. THE COMPLETE DEVICE WAS NOT RETURNED. THE BATTERY PACK WAS RETURNED ON JULY 18, 2016. VISUAL INSPECTION NOTED THAT THE BATTERIES HAD SPLIT OPEN AND LEAKED. THE ELECTRICAL CABLE HAD BEEN SEVERED. THE BATTERY PACK WAS THE ONLY ITEM RETURNED. FUNCTIONAL TESTING OF THE BATTERY PACK AND/OR BATTERIES WAS NOT POSSIBLE DUE TO THE CONDITION OF THE BATTERY PACK AND BATTERIES. THE CUSTOMERS REPORTED EVENT WAS CONFIRMED AT INCOMING INSPECTION. THE ROOT CAUSE FOR THIS EVENT IS IMPROPER DISPOSAL OF THE DEVICE IN CONTRADICTION OF THE INSTRUCTIONS FOR USE (IFU). SEVERING THE ELECTRICAL CABLE WITH THE BATTERIES STILL IN PLACE CAN CAUSE AN ELECTRICAL SHORT INITIATING THE BATTERIES SPLITTING OPEN OR ANODE EXPULSIONS. THE DEVICE INSTRUCTIONS FOR USE AND THE LABELING ON THE (B)(6) 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 IFU 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.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT WHEN CLEANING THE OPERATING ROOM AFTER SURGERY, TEAM MEMBER NOTED SMOKE COMING OUT OF ITEM AND THAT IT SEEMED THE BATTERIES WERE MELTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472435 FAN SPRAY KIT FAN SPRAY KIT FQH ZIMMER SURGICAL, INC. N/A 63177784

    Patients

    Seq Age Sex Outcome Treatment
    1