BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061683 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00838
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY NOT HOLDING A CHARGE) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY WAS UNABLE TO RECHARGE OR POWER UP A MONITOR. THE CAUSE FOR THE BATTERY FAILURE WAS ISOLATED TO A CORRODED BATTERY PCA BOARD. THE ROOT CAUSE FOR THE CORROSION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY INGRESS OF AN UNKNOWN LIQUID. NO ADVERSE EVENT RESULTED FROM THE CORRODED PCA BOARD. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY WASN'T HOLDING A CHARGE. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130852 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR