BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYS

    MDR report key: 3761138 · Received December 31, 2013

    Report

    Report Number
    3008642652-2013-03753
    Event Type
    Malfunction
    Date Received
    December 31, 2013
    Date of Event
    December 3, 2013
    Report Date
    December 31, 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 OF MONITOR SN (B)(4) HAS BEEN COMPLETED. UPON RECEIPT THE MONITOR WAS UNABLE TO DETECT AN ECG SIGNAL. UPON INVESTIGATION THE DRIVEN GROUND MONITOR SIGNAL WIRE WAS PINCHED IN THE BELT CONNECTOR AND COMPONENT U611, A 50MA LOW DROPOUT LINEAR REGULATOR, HAD NO OUTPUT. THE CAUSE FOR THE INABILITY TO DETECT AN ECG SIGNAL WAS THE PINCHED WIRE AND THE DEFECTIVE U611 COMPONENT. THE ROOT CAUSE FOR THE PINCHED WIRE AND THE DEFECTIVE U611 COMPONENT CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA HAS DETECTED A REPORTABLE EVENT. UPON SERVICING, MONITOR SN (B)(4) WAS UNABLE TO DETECT THE ECG SIGNAL. THE LAST PT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682533 LIFEVEST WCD 4000 SYS WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA