BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2110354 · Received April 21, 2011

    Report

    Report Number
    3002158293-2011-00462
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    February 8, 2011
    Report Date
    April 21, 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 PROBLEMS (BATTERY/CHARGER FAULTS, BATTERY WOULD NOT CHARGE OR POWER MONITOR) HAVE BEEN CONFIRMED. UPON EVALUATION THE BATTERY OUTPUT VOLTAGE WAS MEASURED AT 1.80V AND THE BATTERY HAD MISMATCHED TRI-CELLS MEASURING 0.922V, 0.913V AND 0.023V. THE CAUSE FOR THE DEFECTIVE CELLS CANNOT BE POSITIVELY DETERMINED. DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEMS (BATTERY/CHARGER FAULTS, BATTERY WOULD NOT CHARGE OR POWER MONITOR) HAVE BEEN CONFIRMED. UPON EVALUATION THE BATTERY OUTPUT VOLTAGE WAS MEASURED AT 1.88V AND THE BATTERY HAD MISMATCHED TRI-CELLS MEASURING 0.629V, 0.623V AND 0.231V. THE CAUSE FOR THE DEFECTIVE CELLS CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACKS. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACKS. DEVICE MANUFACTURE DATE: BATTERY PACK SN (B)(4): 10/2007, BATTERY PACK SN (B)(4): 02/2009.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT NEITHER OF THE HIS BATTERIES WILL POWER UP HIS MONITOR. THE PATIENT WAS ISSUED TWO REPLACEMENT BATTERY PACKS AND A BATTERY CHARGER.

    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 67 YR