BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 2171819 · Received July 22, 2011

    Report

    Report Number
    2031642-2011-00229
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATTERY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BACKUP BATTERY IS NOT CHARGING. THE VENTILATOR WAS NOT IN USE ON A PATIENT, AND THERE WAS NO PATIENT HARM. REVIEW OF THE VENTILATOR'S DIAGNOSTIC LOG REVEALED THAT WHEN THE VENTILATOR WAS POWERED ON BY THE USER IT DISPLAYED A MESSAGE 'BACKUP BATTERY NOT CONNECTED', INDICATING TO THE USER THAT THE BATTERY IN PLACE FOR BACKUP POWER HAD A LOW CAPACITY FOR USE. THERE WAS ALSO A CODE IN THE DIAGNOSTIC LOG INDICATING A 24/+-12V/POWER FAIL OCCURRENCE. THE MANUFACTURER'S SERVICE TECHNICIAN CONFIRMED THE BACKUP BATTERY WOULD NOT FUNCTION. THE SERVICE TECHNICIAN REPLACED THE BACKUP BATTERY TO ADDRESS THE REPORTED PROBLEM. PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED TO OPERATING SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1