BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2946247 · Received January 4, 2013

    Report

    Report Number
    3008642652-2012-03333
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    November 28, 2012
    Report Date
    December 17, 2012
    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 EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORT PROBLEM (NOT CHARGING BATTERY PACKS) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER WAS UNABLE TO CHARGE BATTERY PACKS. 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 CONTAMINATED BATTERY BOARD. THE PT REC'D A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER/MODEM WAS NOT CHARGING HIS BATTERIES. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5586 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR