BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3872607 · Received May 23, 2014

    Report

    Report Number
    3008642652-2014-01539
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 20, 2014
    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 EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION, THE MONITOR FAILED PULSE TESTING. THE NEGATIVE PAD OF CAPACITOR C10 WAS LIFTED CAUSING A SHORT. THE CAUSE FOR THE TEST FAILURES WAS ISOLATED TO A DEFECTIVE C10 CAPACITOR ON THE C/A BOARD. THE ROOT CAUSE FOR THE DAMAGED C10 CAPACITOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE SHORTED CAPACITOR. THE PT RECEIVED A REPLACEMENT MONITOR.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. UPON SERVICING OF MONITOR SN (B)(4), THE MONITOR FAILED INCOMING PULSE TESTING. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307489 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA