BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3000 SYSTEM

    MDR report key: 4568517 · Received February 26, 2015

    Report

    Report Number
    3008642652-2015-01032
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    February 4, 2015
    Report Date
    February 26, 2015
    Manufacturer
    ZOLL MANUFACTURING CORPORATION
    Product Code
    NVK
    PMA / PMN Number
    P010030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOES NOT COMMUNICATE WITH A MONITOR) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING FUNCTIONALITY TESTING. UPON INVESTIGATION THE ELECTRODE BELT HAS BENT TRUNK CABLE CONNECTOR PINS. THE ROOT CAUSE FOR THE BENT PINS COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE WHEN CONNECTING THE ELECTRODE BELT TO A MONITOR. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.

    Description of Event or Problem · 1

    A ZOLL DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) TO REPORT THAT THE BELT COULD NOT COMMUNICATE WITH A MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137414 LIFEVEST WCD 3000 SYSTEM WEARABEL CARDIOVERTER DEFIBRILLATOR NVK ZOLL MANUFACTURING CORPORATION WCD 3000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA