BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3192355 · Received June 18, 2013

    Report

    Report Number
    3008642652-2013-01601
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ZOLL LIFECOR
    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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE CABLE CONNECTING THE REAR THERAPY ELECTRODES (TE) AND THE DISTRIBUTION NODE(DN) WAS PULLED FORM THE STRAIN RELIEF AT THE DN. THE CAUSE OF THE PULSE LEAD HI-POT FAILURE IS THE PULLED CABLE. THE ROOT CAUSE OF THE DAMAGED CABLE AND INTERNAL WIRES CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CABLE AND WIRES. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, BELT SN (B)(4) FAILED THE PULSE LEAD HI-POT TEST. THE LAST PT TO USE THIS BELT DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276165 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA