BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3072309 · Received April 5, 2013

    Report

    Report Number
    3008642652-2013-00928
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 29, 2013
    Report Date
    April 2, 2013
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL SUMMARY - DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVAL, THE PULSE WIRE WAS OPEN INSIDE OF THE CABLE CONNECTING ECG "B" TO THE DISTRIBUTION NODE, WHICH CAUSED THE THERAPY ELECTRODE RECOGNITION FAILURE. THE ROOT CAUSE FOR THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, ELECTRODE BELT SN (B)(4) FAILED A THERAPY ELECTRODE RECOGNITION TEST. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141665 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA