BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPAP PRO

    MDR report key: 2201974 · Received August 5, 2011

    Report

    Report Number
    2518422-2011-00083
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 7, 2011
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K011714
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A CAREGIVER ALLEGED THAT HER FAMILY MEMBER HAD BEEN HOSPITALIZED FOR LOW OXYGEN SATURATION BECAUSE, THE PT WAS UNABLE TO USE A BI-LEVEL POSITIVE AIRWAY PRESSURE DEVICE (BIPAP). THE BIPAP DEVICE IN QUESTION REPORTEDLY WOULD NOT POWER ON. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MFR FOR EVAL. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC. 1007216

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization