BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 7773445 · Received August 10, 2018

    Report

    Report Number
    3008642652-2018-06898
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    June 22, 2018
    Report Date
    August 7, 2018
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    UDI-DI
    00855778005012
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK THERAPY PAD MESSAGES) HAS BEEN CONFIRMED. THE REPORTED PROBLEM (CHECK THERAPY PAD MESSAGES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST. THE CABLE CONNECTING ECG A AND B TO FRONT TE WAS CUT, DAMAGING WIRES WITHIN THE CABLE. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN CUT PULSE WIRE IN THE CABLE CONNECTING ECG "A" AND ECG "B" AND A CUT -5V WIRE CONNECTING ECG "A" AND ECG "B" TO THE FRONT TE. THE ROOT CAUSE FOR THE CUT WIRES WAS EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED A PATIENT'S ELECTRODE BELT AND REPORTED THAT THE PATIENT WAS EXPERIENCING "CHECK THERAPY PAD" MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612368 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 4000 00855778005012

    Patients

    Seq Age Sex Outcome Treatment
    1