BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEVEST WCD 4000 SYSTEM

    MDR report key: 3061711 · Received March 29, 2013

    Report

    Report Number
    3008642652-2013-00842
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 26, 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 BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. UPON EVALUATION THE PINS ON BATTERY CHARGER POWER SUPPLY CONNECTOR WERE RECESSED, WHICH PREVENTED THE BATTERY CHARGER/MODEM FROM POWERING UP. THE ROOT CAUSE FOR THE RECESSED PINS COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM. THE LAST PATIENT TO USE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Description of Event or Problem · 1

    A REVIEW OF SERVICE DATA DETECTED A REPORTABLE PROBLEM. DURING SERVICING, BATTERY CHARGER/MODEM SN (B)(4) WAS UNABLE TO POWER UP. THE LAST PATIENT TO USE THIS BATTERY CHARGER/MODEM DID NOT REPORT ANY DEFICIENCIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129730 LIFEVEST WCD 4000 SYSTEM WEARABLE CARDIOVERTER DEFIBRILLATOR MVK ZOLL LIFECOR CORPORATION WCD 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA