BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1983752 · Received February 4, 2011

    Report

    Report Number
    3002158293-2011-00120
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    November 22, 2010
    Report Date
    February 2, 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

    SN (B)(4), ADD'L MFR DATE: (B)(6) 2008. DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY PROBLEM) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY CONNECTOR WAS DAMAGED AND PIN 2 WAS BENT. THE CAUSE FOR THE DAMAGED CONNECTOR AND BENT PIN CANNOT BE POSITIVELY IDENTIFIED. DEVICE EVALUATION OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY/CHARGER FAULTS) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY WAS FOUND TO HAVE DEFECTIVE CELLS MEASURING AT 1.250V, 0.080V AND 0.470V. THE CAUSE FOR THE DEFECTIVE CELLS CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A TERRITORY MANAGER (TM) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) FEMALE PATIENT TO REPORT THAT NEITHER OF THE PATIENT'S BATTERIES WILL CHARGE. THE PATIENT WAS ISSUED TWO REPLACEMENT BATTERY PACKS.

    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 57 YR