BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2221444 · Received August 17, 2011

    Report

    Report Number
    3008642652-2011-00478
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    July 23, 2011
    Report Date
    August 17, 2011
    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 CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT CHARGE BATTERY/ "INSERT BATTERY" MESSAGE) HAS BEEN CONFIRMED. UPON EVAL, THE BATTERY CHARGER CONNECTOR WAS CORRODED. THE CORROSION ON THE CONNECTOR DID NOT ALLOW THE CHARGER TO DETECT A BATTERY WHEN INSERTED. THE ROOT CAUSE OF THE CORROSION CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF LIQUID INGRESS. NO ADVERSE EVENT RESULTED FROM THE CORRODED CONNECTOR. THE PT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER CHARGER/MODEM WAS NOT CHARGING HER BATTERIES AND DISPLAYS THE MESSAGE "INSERT BATTERY" WHEN A BATTERY IS INSERTED. THE PT WAS ISSUED A REPLACEMENT CHARGER/MODEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR