BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP VISION

    MDR report key: 4162476 · Received October 9, 2014

    Report

    Report Number
    2518422-2014-01705
    Event Type
    Death
    Date Received
    October 9, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    PMA / PMN Number
    K982454
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR'S FIELD SERVICE TECHNICIAN EVALUATED THE DEVICE AT THE REPORTING FACILITY. THE TECHNICIAN FOUND THE DEVICE TO OPERATE AND ALARM AS DESIGNED. THE DEVICE'S ERROR LOG WAS REVIEWED, VENTILATOR INOPERATIVE CODES WERE OBSERVED IN THE LOG. THE MFR WAS UNABLE TO DETERMINE THE ACTUAL TIME AND DATE OF THE VENTILATOR INOPERATIVE CODES. THE ICB CABLE WAS REPLACED TO ADDRESS THE LOGGED ERRORS. THE DEVICE PASSED ALL FINAL TESTING.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFO ALLEGING A PT EXPIRED WHILE USING A BIPAR VISION. THE REPORTING FACILITY STATED THE PT'S MASK WAS NOT FULLY ON THE PT'S FACE AT THE TIME OF THE EVENT. THE REPORTING FACILITY WAS UNABLE TO CONFIRM IF THE DEVICE ALARMED DURING THE EVENT. THE DEVICE WAS TURNED OFF BY THE NURSING STAFF PRIOR TO THE PT EXPIRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635471 BIPAP VISION VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE CBK RESPIRONICS, INC. 582059

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death