BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2920643 · Received December 7, 2012

    Report

    Report Number
    3008642652-2012-03247
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 6, 2012
    Manufacturer
    ZOLL LIFECOR CORP
    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 PROBLEM (BATTERY FAULTS) WAS CONFIRMED. UPON INVESTIGATION THE WHITE WIRE WAS BROKEN FROM THE BATTERY CELLS, WHICH CAUSED THE REPORTED BATTERY FAULTS. THE ROOT CAUSE FOR THE BROKEN WIRE COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FORM THE BATTERY PACK IMPACTING A HARD SURFACE. NO ADVERSE EVENT RESULTED FROM BROKEN WHITE WIRE. THE PT RECEIVED A REPLACEMENT BATTERY PACK.

    Description of Event or Problem · 1

    DOWNLOAD DATA FROM A (B)(6) MALE PT REVEALED SEVERAL BATTERY FAULTS. ZOLL CUSTOMER SUPPORT CONTACTED THE PT AND ISSUED HIM 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 CORP WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR