BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3002519 · Received February 15, 2013

    Report

    Report Number
    3008642652-2013-00365
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) WAS CONFIRMED. UPON EVALUATION, THE POWER BRICK WAS DEFECTIVE. THE CAUSE OF THE DEFECTIVE POWER BRICK IS A DAMAGED CONNECTOR. THE CONNECTOR PINS WERE RECESSED INTO THE CONNECTOR. THE ROOT CAUSE OF THE RECESSED PINS CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE CHARGER/MODEM. THE PATIENT RECEIVED A REPLACEMENT CHARGER/MODEM.

    Description of Event or Problem · 1

    A PHYSICIAN ASSISTANT (PA) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE'S BATTERY CHARGER MODEM WOULD NOT STAY POWERED ON. THE PA REPORTED THAT THE CHARGER HAD A LOOSE POWER CONNECTION. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER/MODEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67753 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR