BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIPAP AVAPS C-SERIES

    MDR report key: 3063126 · Received April 11, 2013

    Report

    Report Number
    2518422-2013-00584
    Event Type
    Other
    Date Received
    April 11, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    RESPIRONICS INC.
    Product Code
    MNS
    PMA / PMN Number
    K092818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OCCUPATIONAL THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EVALUATED BY THE MFR. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED. THE DEVICE OPERATED TO DESIGN SPECIFICATIONS AND PASSED ALL TESTING.

    Description of Event or Problem · 1

    THE MFR RECEIVED INFORMATION ALLEGING A BIPAP C-SERIES WAS NOT ABLE TO BE POWERED ON. THE PT WAS ADMITTED TO THE HOSPITAL AS A RESULT. THE PT WAS DISCHARGED FROM THE HOSPITAL WITH A VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155711 BIPAP AVAPS C-SERIES VENTILATOR, CONTINUOUS, NON-LIFE SUPPORTING MNS RESPIRONICS INC. 1060657 1060657

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization