BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2110343 · Received April 21, 2011

    Report

    Report Number
    3002158293-2011-00457
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 20, 2011
    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 PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY/CHARGER FAULTS) HAS BEEN CONFIRMED. UPON EVALUATION THE BATTERY WAS FOUND TO HAVE A BLOWN FUSE, PREVENTING IT FROM CHARGING AND POWERING A MONITOR. THE CAUSE FOR THE BLOWN FUSE CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE BLOWN FUSE. THE PSR RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A PATIENT SERVICE REPRESENTATIVE (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A BATTERY THAT WAS TO BE FITTED WITH A PATIENT GENERATES BATTERY/CHARGER FAULTS AND DOES NOT POWER UP A MONITOR. THE PSR WAS ISSUED A REPLACEMENT CHARGER AND BATTERY PACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA