BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3002523 · Received February 15, 2013

    Report

    Report Number
    3008642652-2013-00400
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 11, 2013
    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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) HAS BEEN CONFIRMED. UPON INVESTIGATION, THE BATTERY CHARGER WOULD NOT POWER ON. THE CAUSE WAS A DEFECTIVE CONNECTOR ON THE POWER SUPPLY BRICK THAT PLUGS INTO THE CHARGER. THE PINS WERE RECESSED IN THE POWER BRICK CONNECTOR. THE ROOT CAUSE OF THE DEFECTIVE CONNECTOR CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PATIENT WAS PROVIDED WITH A REPLACEMENT CHARGER.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A BATTERY CHARGER/MODEM SHE HAD WOULD NOT POWER ON. THE PSR WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66572 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA