BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIPAP AUTO

    MDR report key: 1884961 · Received October 21, 2010

    Report

    Report Number
    2518422-2010-00113
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 22, 2010
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    PMA / PMN Number
    K050759
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF PRODUCT LABELING FOR THE BIPAP AUTO (USER MANUAL, PART NUMBER 1023952, SECTION, INTENDED USE) STATES "THE BIPAP AUTO WITH BI-FLEX SYSTEM DELIVERS POSITIVE AIRWAY PRESSURE THERAPY FOR THE TREATMENT OF ADULT OBSTRUCTIVE SLEEP APNEA (OSA) ONLY." LOSS OF THERAPY FOR THE PT POPULATION DOES NOT REPRESENT A SIGNIFICANT RISK TO THE INTENDED USER. THE MANUFACTURER DETERMINED THAT THE CUSTOMER'S ALLEGATION OF THE DEVICE'S PRESSURE DECREASING AND NOT CYCLING PROPERLY COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION OF THE DEVICE AND THE INFORMATION AVAILABLE, THE MANUFACTURER CONCLUDES THAT THE CAUSE OF THE HOSPITALIZATION WAS RELATED TO THE DISEASE STATE OF THE PT. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO THE MANUFACTURER A BIPAP AUTO DEVICE PRESSURE DECREASED WHILE IN USE ON A PT. THE PT WAS TAKEN TO THE HOSPITAL FOR SHORTNESS OF BREATH AND ADMITTED TO THE HOSPITAL. WHILE THE PT WAS USING THE BIPAP IN THE HOSPITAL THE DEVICE ALLEGEDLY STOPPED CYCLING PROPERLY, THE PRESSURE PROVIDED TO THE PT DECREASED, AND THE PT ARRESTED. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED AND THE PT RECOVERED AND WAS PLACED ON ANOTHER DEVICE. THE PT WAS DISCHARGED TWO DAYS LATER AND IS NOW ON CONTINUOUS OXYGEN THERAPY. THE DEVICE WAS RETURNED AND EVALUATED BY THE MANUFACTURER. THE CUSTOMER'S ALLEGED COMPLAINT WAS NOT CONFIRMED BY THE MANUFACTURER. THE MANUFACTURER CONFIRMED THE PRESSURE OUTPUT OF THE DEVICE DID SLIGHTLY FLUCTUATE BUT THE OBSERVED FLUCTUATION WAS WITHIN DESIGN SPECIFICATION. THE ERROR LOG OF THE BIPAP WAS REVIEWED AND FOUND TO CONTAIN NO LOGGED ERROR CODES. THE DEVICE PASSED ALL STANDARD FUNCTIONAL AND OPERATIONAL TESTING DURING THE INVESTIGATION. THE PT HAS A MEDICAL HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE AND OBSTRUCTIVE SLEEP APNEA. THE DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) REPORTED THE PT GETS ANXIOUS AND IS ADMITTED TO THE HOSPITAL WITH BREATHING COMPLICATIONS FREQUENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC. U1017439

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization