BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3090054 · Received April 19, 2013

    Report

    Report Number
    3008642652-2013-01042
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Date of Event
    March 24, 2013
    Report Date
    April 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 EVAL OF BATTERY PACK SN (B)(4), HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER FAULTS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY WAS NON-FUNCTIONAL IN A TEST CHARGER AND TEST MONITOR. THE CAUSE FOR THE NON-FUNCTIONAL BATTERY WAS A BLOWN BATTERY FUSE. THE ROOT CAUSE FOR THE BLOWN FUSE WAS UNABLE TO BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE BLOWN BATTERY FUSE. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE CHARGER/MODEM WAS ALARMING. WHEN PROMPTED TO DOWNLOAD, THE PT'S FLAGS REVEALED 4 CHARGER FAULTS ON BATTERY PACK SN (B)(4). THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169404 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR