BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2310589 · Received October 18, 2011

    Report

    Report Number
    3008642652-2011-00823
    Event Type
    Malfunction
    Date Received
    October 18, 2011
    Date of Event
    September 8, 2011
    Report Date
    October 17, 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 EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE BATTERY WOULD NOT CHARGE ON THE CHARGER AND DID NOT POWER UP A MONITOR. UPON SERVICE INVESTIGATION, THE BATTERY CELLS WERE FOUND TO HAVE A LOW OUTPUT VOLTAGE OF 1.92V. THE CAUSE FOR THE DEFECTIVE CELLS CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PCK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    A (B)(6) MALE PT CONTACT ZOLL CUSTOMER SUPPORT TO REPORT A BATTERY PACK FAULT. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.

    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 58 YR