BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 2821967 · Received September 28, 2012

    Report

    Report Number
    3008642652-2012-02550
    Event Type
    Malfunction
    Date Received
    September 28, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 25, 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 EVAL SUMMARY: DEVICE EVAL OF CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. UPON EVAL, THE POWER SUPPLY WAS DEFECTIVE. THE CAUSE OF THE DEFECTIVE POWER BRICK IS A DAMAGED CONNECTOR. THE CONNECTOR PINS WERE RECESSED INTO THE CONNECTOR. THE ROOT CAUSE OF THE RECESSED PINS CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY A RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED POWER BRICK CONNECTOR. THE LAST PT TO USE THIS CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, CHARGER/MODEM SN (B)(4) WAS FOUND TO HAVE A DEFECTIVE POWER SUPPLY. THE LAST PT TO USE THIS CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA