BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1910190 · Received November 30, 2010

    Report

    Report Number
    2031642-2010-00316
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 4, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRINTED CIRCUIT BOARD (PCB); POWER SUPPLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR WENT VENT INOP AND ALARMED WHILE IN USE ON A PATIENT. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM. THE MANUFACTURER'S SERVICE TECHNICIAN VERIFIED THE VENT INOP UPON POWER ON OF THE VENTILATOR FOR EVALUATION. THE SERVICE TECHNICIAN CONFIRMED A DIAGNOSTIC CODE IN THE VENTILATOR LOG HISTORY THAT INDICATED A VENTILATOR RESTART HAD OCCURRED WITH A VENT INOP OCCURRENCE. THE SERVICE TECHNICIAN REPLACED THE POWER SUPPLY AND VGA PCB BOARD TO ADDRESS THE FINDINGS. EXTENDED SELF TESTING AND 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