BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 3003703 · Received February 12, 2013

    Report

    Report Number
    3008642652-2013-00242
    Event Type
    Malfunction
    Date Received
    February 12, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 22, 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 EVAL SUMMARY: DEVICE EVAL OF BATTERY CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (LOOSE POWER CORD/ LOSES POWER) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER WOULD NOT POWER ON. THE CAUSE OF THE INABILITY TO POWER ON IS A DEFECTIVE POWER UNIT. THE CAUSE OF THE DEFECTIVE POWER UNIT IS DISCONNECTED PINS IN THE CONNECTOR. THE ROOT CAUSE FOR THE DISCONNECTED PINS CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER UNIT. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A PATIENT SERVICE REP (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) FEMALE PATIENT TO REPORT THAT THE POWER CORD WAS NOT SECURE CAUSING THE CHARGER TO LOSE POWER. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61317 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR