BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3221460 · Received July 2, 2013

    Report

    Report Number
    3008642652-2013-01766
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 1, 2013
    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 SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON INVESTIGATION THE MONITOR WAS UNABLE TO DETECT THE ELECTRODE BELT ECG ELECTRODES. THE FAILURE WAS ISOLATED TO AN OPEN R781 DRIVEN GROUND RESISTOR ON THE MONITOR C/A BOARD. THE ROOT CAUSE FOR THE OPEN RESISTOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE OPEN RESISTOR. THE PATIENT IS SCHEDULED TO BE FIT WITH AN ICD AND ENDED USE.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT RETURNED A MONITOR FOR AN UNRELATED EVENT. UPON SERVICE INVESTIGATION, THE MONITOR FAILED INCOMING TESTING. THE PATIENT IS SCHEDULED TO BE FIT WITH AN ICD AND ENDED USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301905 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR