BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3080796 · Received April 12, 2013

    Report

    Report Number
    3008642652-2013-00984
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 23, 2013
    Report Date
    April 5, 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 (WON'T POWER ON) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER/ MODEM WOULD NOT POWER ON. UPON EVALUATION, THE POWER SUPPLY UNIT WAS DEFECTIVE. THE CAUSE OF THE INABILITY TO POWER ON IS THE DEFECTIVE POWER SUPPLY UNIT. THE ROOT CAUSE OF THE DEFECTIVE POWER SUPPLY UNIT CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) MALE PATIENT TO REPORT THAT THE BATTERY CHARGER WOLD NOT POWER ON. THE PATIENT WAS ISSUED A REPLACEMENT CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159635 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR