BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3190992 · Received June 21, 2013

    Report

    Report Number
    3008642652-2013-01635
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 14, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK THERAPY PAD MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST. THE BLACK PULSE WIRE WAS OPEN IN THE TRUNK CABLE INSULATION. THE OPEN PULSE WIRE CAUSED THE REPORTED ALARMS. THE ROOT CAUSE FOR THE OPEN PULSE WIRE COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM EXCESSIVE FORCE ON THE ELECTRODE BELT TRUNK CABLE. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE. THE PT REC'D A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT'S WIFE CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT WAS RECEIVING FREQUENT CHECK THERAPY ELECTRODE PAD MESSAGES. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283181 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR