BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2881097 · Received November 16, 2012

    Report

    Report Number
    3008642652-2012-03013
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 12, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ZOLL LIFECOR CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 BELT ALARMS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE PULSE WIRE WAS OPEN IN THE ELECTRODE BELT CABLE CONNECTING THE DISTRIBUTION NODE (DN) AND ECG "B", WHICH CAUSED THE REPORTED ALARMS. THE ROOT CAUSE FOR THE OPEN WIRE COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM EXCESSIVE FORCE ON THE CABLE SECTION. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    A (B)(6) MALE PT REPORTED TO ZOLL CUSTOMER SUPPORT THAT HE WAS RECEIVING FREQUENT CHECK BELT ALARMS. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR