BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 1912989 · Received November 18, 2010

    Report

    Report Number
    3002158293-2010-01231
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    September 30, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY/CHARGER FAULT) WAS CONFIRMED. UPON EVAL, THE BATTERY PACK WAS FOUND TO HAVE MISMATCHED CELLS, WITH ONE CELL READING 0.071 VOLTS. THE ROOT CAUSE OF THE MISMATCHED CELLS CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(4) DISTRIBUTOR CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT BATTERY (B)(4) NEEDED REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA