BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3844882 · Received March 12, 2014

    Report

    Report Number
    3008642652-2014-00510
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    January 26, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER FAULTS) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE BATTERY CHARGER WAS UNABLE TO CHARGE A BATTERY PACK. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A CONTAMINATED BATTERY BOARD. THE ROOT CAUSE FOR THE CONTAMINATION WAS INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE CONTAMINATION. THE PT REC'D A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A ZOLL PT SERVICE REP (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) FEMALE PT WAS RECEIVING BATTERY CHARGER FAULTS. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149552 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR