BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221464 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01650
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ZOLL LIFECOR
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER NOT WORKING) WAS CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/MODEM WAS RESETTING. THE CAUSE FOR THE FAILURE WAS ISOLATED TO CORROSION ON THE BATTERY BOARD AND BEDSIDE BOARD. THE ROOT CAUSE FOR THE CORROSION WAS INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FORM THE CONTAMINATION. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER BATTERY CHARGER/MODEM WAS NOT WORKING PROPERLY AND SHE COULD SMELL SOMETHING BURNING. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300666 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR