BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3112108 · Received May 3, 2013

    Report

    Report Number
    3008642652-2013-01166
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 29, 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 OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) WAS CONFIRMED. UPON RECEIPT, THE POWER BRICK WAS DEFECTIVE. THE ROOT CAUSE FOR THE DEFECTIVE POWER SUPPLY BRICK COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FORM THE DEFECTIVE BATTERY CHARGER POWER BRICK. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY CHARGER WOULD NOT POWER ON. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY CHARGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195621 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR