BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3210052 · Received June 27, 2013

    Report

    Report Number
    3008642652-2013-01704
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT, CHECK THERAPY ELECTRODE ALARMS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE WHITE PULSE WIRE WAS FOUND TO BE OPEN IN THE TRUNK CABLE INSULATION, CAUSING THE REPORTED ALARMS. THE ROOT CAUSE FOR THE OPEN PULSE WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE ON THE TRUNK CABLE SECTION. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A ZOLL PATIENT SERVICE REPRESENTATIVE (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PATIENT WAS RECEIVING ADJUST BELT AND CHECK THERAPY ELECTRODE ALARMS. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292329 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR