BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESPRIT VENTILATOR

    MDR report key: 1931645 · Received December 17, 2010

    Report

    Report Number
    2031642-2010-00339
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    RESPIRONICS CALIFORNIA, INC.
    Product Code
    CBK
    PMA / PMN Number
    K981072
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRINTED CIRCUIT BOARD (PCB).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE VENTILATOR ALARMED VENT INOP DURING OPERATION. THE CUSTOMER REPORTED THE VENTILATOR WAS NOT IN USE, THEREFORE THERE WAS NO PATIENT HARM OR INVOLVEMENT. THE MANUFACTURER'S SERVICE TECHNICIAN WAS UNABLE TO DUPLICATE THE CUSTOMER REPORTED PROBLEM. THE SERVICE TECHNICIAN REPORTED WHEN THE VENTILATOR WAS POWERED ON ONLY A WHITE SCREEN WAS DISPLAYED ON THE MONITOR, AND THE VENTILATOR WOULD NOT PROCEED INTO POWER ON SELF TESTING. THE SERVICE TECHNICIAN REPLACED THE VGA PCB TO CORRECT THE FINDING. EXTENDED SELF TESTING AND PERFORMANCE VERIFICATION TESTING WAS COMPLETED AND TESTS PASSED PER OPERATING SPECIFICATIONS. FAILURE OF THE VGA PCB BOARD MAY RESULT IN A SHUT DOWN OF THE VENTILATOR IF IT OCCURS DURING OPERATION. IF A FAILURE OF THE VENTILATOR OCCURS DURING USE AND THE VENTILATOR SHUTS DOWN, AN AUDIBLE POWER FAIL ALARM WILL ACTIVATE.

    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