BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221494 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01737
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ZOLL LIFECOR CORP
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 THERAPY PAD MESSAGES) WAS CONFIRMED. UPON INVESTIGATION THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE (TE) CABLE WAS PULLED FROM THE STRAIN RELIEF. THIS RESULTED IN AN INTERMITTENT CONNECTION BETWEEN THE CABLE AND DN. THE ROOT CAUSE OF THE DAMAGED CABLE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FORM THE DAMAGED CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT CHECK THERAPY PAD MESSAGES. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300673 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR