BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3851320 · Received March 26, 2014

    Report

    Report Number
    3008642652-2014-00858
    Event Type
    Malfunction
    Date Received
    March 26, 2014
    Date of Event
    February 18, 2014
    Report Date
    March 26, 2014
    Manufacturer
    ZOLL LIFECOR CORP.
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHECK THERAPY ELECTRODE MESSAGES, CONNECTOR WON'T LATCH) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED A THERAPY ELECTRODE RECOGNITION TEST AND THE TRUNK CABLE CONNECTOR WOULDN'T LATCH. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN OPEN PULSE WIRE IN THE CABLE CONNECTING THE DISTRIBUTION NODE AND ECG "B". THERE WAS NO SIGN OF EXTERNAL DAMAGE TO THE CABLE. THE ROOT CAUSE FOR THE OPEN PULSE WIRE AND DEFECTIVE TRUNK CABLE CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN PULSE WIRE. THE PATIENT RECEIVED A REPLACEMENT ELECTRODE BELT.

    Description of Event or Problem · 1

    THE WIFE OF A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT WAS RECEIVING CHECK THERAPY ELECTRODE ALARMS AND HIS ELECTRODE BELT WOULDN'T STAY CONNECTED TO HIS MONITOR. THE PATIENT WAS ISSUED A REPLACEMENT ELECTRODE BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176635 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORP. WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR