BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 5239849 · Received November 20, 2015

    Report

    Report Number
    3008642652-2015-07648
    Event Type
    Malfunction
    Date Received
    November 20, 2015
    Date of Event
    October 10, 2015
    Report Date
    November 20, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    MVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (ADJUST BELT ALARMS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED AN ECG FALL-OFF TEST. THE CAUSE FOR THE ECG FAILURE WAS ISOLATED TO A SOLDER JOINT ON THE DISTRIBUTION NODE (DN) PCA. THE SOLDER JOINT WHERE THE ECG "B" CABLE CONNECTS TO THE DN WAS INTERMITTENT, CAUSING THE REPORTED ALARMS. THE ROOT CAUSE FOR THE INTERMITTENT SOLDER JOINT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A US DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4). THE PATIENT USING THIS ELECTRODE BELT WAS RECEIVING FREQUENT ADJUST BELT MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770552 LIFEVEST WCD 3000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL MANUFACTURING CORPORATION WCD 3000

    Patients

    Seq Age Sex Outcome Treatment
    1