BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3191006 · Received June 21, 2013

    Report

    Report Number
    3008642652-2013-01645
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 (NOT PROPERLY DETECTED INSERTED BATTERY PACKS) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS UNABLE TO PROPERLY DETECT WHEN A BATTERY PACK WAS INSERTED. THE CAUSE FOR THE FAILURE WAS ISOLATED TO CONTAMINATION ON THE BATTERY BOARD. THE ROOT CAUSE FOR THE CONTAMINATION COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY 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

    THE WIFE OF A (B)(6) MALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S BATTERY CHARGER/MODEM WAS NOT PROPERLY DETECTING INSERTED BATTERY PACKS. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282472 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR