BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 2251303 · Received August 12, 2011

    Report

    Report Number
    3008642652-2011-00445
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    April 29, 2011
    Report Date
    August 11, 2011
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BELT ALARMS) HAS BEEN CONFIRMED. UPON EVAL, THE TRUNK CABLE HAD A BROKEN WIRE INSIDE THE CABLE INSULATION, RESULTING IN AN OPEN CIRCUIT. THE CAUSE FOR THE BROKEN WIRE WAS A KINK IN THE TRUNK CABLE. THE ROOT CAUSE OF THE KINK IN THE CABLE CANNOT BE POSITIVELY IDENTIFIED. THE OPEN CONNECTION CAUSED SIGNAL LOSS, RESULTING IN THE ALARMS EXPERIENCED BY THE PT. NO ADVERSE EVENT RESULTED FROM THE BROKEN WIRE INSIDE THE TRUNK CABLE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE NURSE OF A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT WAS EXPERIENCING "NON-STOP ALARMS". THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR