BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 3100 SYSTEM

    MDR report key: 2904575 · Received November 30, 2012

    Report

    Report Number
    3008642652-2012-03175
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 29, 2012
    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 EVALUATION, THE C19 CAPACITOR POSITIVE GREEN WIRE WAS DAMAGED, CAUSING THE CAPACITOR TO ARC WHEN CHARGED. THE CAUSE OF THE CAPACITOR VOLTAGE FAULT IS THE ARC AT THE CAPACITOR. THE CAUSE OF THE ARC IS THE DAMAGED GREEN WIRE. THE ROOT CAUSE OF THE DAMAGED GREEN WIRE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY MECHANICAL SHOCK FROM PHYSICAL IMPACT. NO ADVERSE EVENT RESULTED FROM THE DAMAGED WIRE. THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, THERE WAS A CAPACITOR VOLTAGE FAULT ON MONITOR SN (B)(4). THE LAST PATIENT TO USE THIS MONITOR DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEVEST WCD 3100 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 3100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA