BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 3964351 · Received July 29, 2014

    Report

    Report Number
    2031642-2014-00754
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Report Date
    July 10, 2014
    Manufacturer
    REPIRONICS CALIFORNIA, INC
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DURING SERVICE OF THE VENTILATOR, THE MANUFACTURERS FIELD SERVICE ENGINEER (FSE) REPORTED THE UNIT WAS NOT WORKING ON BACKUP BATTERY. DURING EVALUATION, THE FSE REPORTED THAT AT THE REAR OF THE VENTILATOR WHERE THE BACKUP BATTERY IS CONNECTED IT WAS DAMAGED WITH A FORCE OF IMPACT. THE FSE REPLACED THE BATTERY TO ADDRESS THE DAMAGE AND REPORTED PROBLEM. FINAL APPLICABLE TESTING WAS PERFORMED AND PASSED TO OPERATING SPECIFICATIONS. POWER FAILURE DUE TO LOSS OF AC OR BATTERY POWER MAY RESULT IN SHUTDOWN OF DEVICE DURING NORMAL VENTILATION OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441435 ESPRIT VENTILATOR VENTILATOR, CONTINUOUS CBK REPIRONICS CALIFORNIA, INC V1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1