BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 1861244 · Received October 1, 2010

    Report

    Report Number
    3002158293-2010-00993
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 6, 2010
    Report Date
    September 30, 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 FAULT/CHARGER FAULT) WAS CONFIRMED. THE CAUSE OF THE BATTERY FAULTS 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 FAULTS" FLAGS IN THE DATA. SUPPORT CONTACTED THE PT TO REPLACE THE SUSPECT BATTERY PACK. THE PT WAS PROVIDED WITH A REPLACEMENT BATTERY PACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR