BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1392029 · Received March 26, 2009

    Report

    Report Number
    3002158293-2009-00194
    Event Type
    Malfunction
    Date Received
    March 26, 2009
    Date of Event
    February 27, 2009
    Report Date
    March 25, 2009
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATES: BATTERY CHARGER - 2006. BATTERY PACK - 2008. BATTERY PACK 2007. DEVICE EVALUATION SUMMARY: DEVICE EVALUATIONS OF BATTERY CHARGER BATTERY PACKS HAVE BEEN COMPLETED. THE REPORTED PROBLEM WAS CONFIRMED. THE CAUSE OF THE FAULT FLAGS WAS CORRODED BATTERY CONTACT TERMINALS IN THE BATTERY CONNECTOR OF THE CHARGER. THE CORROSION PREVENTED PROPER CONTACT WITH THE BATTERY PACK CONNECTOR CONTACTS. THE ROOT CAUSE OF THE CORRODED TERMINALS WAS PROBABLY LIQUID SPILLAGE INTO THE BATTERY WELL AREA OF THE CHARGER. THE CHARGER WAS REPAIRED AND RESTOCKED. BATTERY PACK HAD A CORRODED CONNECTOR. IT LOOKED AS IF THE BATTERY PACK HAD BEEN IN CONTACT WITH SOME LIQUID. BATTERY PACK WAS FULLY FUNCTIONAL. IT WAS RETESTED AND RESTOCKED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CHARGER OR BATTERY PACK. THE PATIENT RECEIVED REPLACEMENT BATTERY PACKS AND CHARGER.

    Description of Event or Problem · 1

    A MALE PATIENT CONTACTED LIFECOR CUSTOMER SUPPORT TO REPORT THAT NEITHER BATTERY PACK WILL POWER UP THE MONITOR. HE STATED THAT BOTH BATTERY PACKS YIELD THE "BATTERY PACK FAULT" LED ON THE BATTERY CHARGER ALONG WITH THE FULLY CHARGED LED. SUPPORT SENT A PATIENT SERVICES REPRESENTATIVE (PSR) TO THE PATIENT AND THE PSR STATED THAT NEITHER BATTERY PACK WOULD CHARGE RELIABLY IN THE CHARGER. SUPPORT HAD THE PSR EXCHANGE THE BATTERY PACKS AND BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR