BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221491 · Received July 3, 2013

    Report

    Report Number
    3008642652-2013-01742
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 27, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ELECTRODE ALARMS) WAS CONFIRMED. UPON INVESTIGATION, THE TRUNK CABLE CONNECTOR WAS DAMAGED AND THE WHITE (DRVN_GND) WIRE INSIDE OF THE CONNECTOR WAS OPEN. THE OPEN WIRE CAUSED THE REPORTED ALARMS. THE ROOT CAUSE FOR THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE ON THE CONNECTOR. NO ADVERSE EVENT RESULTED FROM THE OPEN WHITE WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303696 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR