BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 1760658 · Received July 13, 2010

    Report

    Report Number
    3002158293-2010-00723
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Date of Event
    December 17, 2009
    Report Date
    July 12, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY FAULTS ON DOWNLOAD) WAS CONFIRMED. THE CAUSE OF THE BATTERY NOT FULLY CHARGING WAS A BROKEN WHITE WIRE ON THE BATTERY PCA BOARD WHERE THE WIRE ATTACHES TO THE BATTERY CELLS. THE ROOT CAUSE OF THE BROKEN WIRE HAS NOT BEEN DETERMINED BUT MAY HAVE BEEN CAUSED BY A SEVERE SHOCK FROM DROPPING THE PACK. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK .

    Description of Event or Problem · 1

    DURING A REVIEW OF A (B)(6) FEMALE PT'S DOWNLOAD ZOLL LIFECOR CUSTOMER SUPPORT IDENTIFIED SEVERAL "BATTERY CHARGER FAULT" FLAGS IN THE DATA. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY PACK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR