BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221452 · Received July 3, 2013

    Report

    Report Number
    3008642652-2013-01746
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 (CHECK BELT MESSAGES) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS AN OPEN PULSE WIRE IN THE DISTRIBUTION NODE (DN) TO FRONT TE CABLE, IN THE CABLE PORTION CONNECTING THE DN AND ECG ELECTRODE B. THE CAUSE OF THE CHECK THERAPY PAD MESSAGES IS THE OPEN PULSE WIRE. THE ROOT CAUSE OF THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLES. NO ADVERSE EVENT RESULTED FROM THE OPEN WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A ZOLL PT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT A (B)(6) MALE PT WAS RECEIVING CHECK BELT MESSAGES. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303607 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR