BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP DEVICE

    MDR report key: 1884006 · Received October 14, 2010

    Report

    Report Number
    2518422-2010-00102
    Event Type
    Death
    Date Received
    October 14, 2010
    Date of Event
    September 15, 2010
    Report Date
    September 15, 2010
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER CONTACTED THE REPORTER OF THE EVENT SEVERAL TIMES, AND RECEIVED NO RESPONSE. AS A RESULT, THE MANUFACTURER HAS NOT BEEN ABLE TO DETERMINE THE MODEL OF THE BIPAP DEVICE WHAT WAS ALLEGEDLY INVOLVED IN THE REPORTED EVENT, OR RECEIVED THE UNIT FOR EVAL. IT IS UNK IF THE BIPAP DEVICE HAD THE CAPABILITY TO AUDIBLY ALARM FOR A PT DISCONNECT (SOME MODELS DO NOT), OR IF THE PT DISCONNECT ALARM HAD BEEN ACTIVATED FOR A MODEL THAT DOES HAVE THE CAPABILITY TO AUDIBLY ALARM FOR A PT DISCONNECT. THE INTENDED USE FOR THE MANUFACTURER'S BIPAP DEVICES IS FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA ONLY (MODELS THAT DO NOT OFFER A BACK UP RATE), OR TO PROVIDE NON-INVASIVE VENTILATION IN ADULT PTS (>30 KG) FOR THE TREATMENT OF RESPIRATORY INSUFFICIENCY (A CONDITION IN WHICH THE PT CAN MAINTAIN VENTILATION WITHOUT MECHANICAL SUPPORT FOR SOME PERIOD OF TIME, SUCH AS OVERNIGHT) OR OBSTRUCTIVE SLEEP APNEA (MODELS THAT DO OFFER A BACK UP RATE). BASED ON THE AVAILABLE INFO, THE MANUFACTURER DETERMINED THE DEVICE WAS BEING USED IN AN OFF LABEL MANNER. LOSS OF THERAPY FOR THE INTENDED PT POPULATION DOES NOT REPRESENT A SIGNIFICANT RISK TO THE USER. THE MANUFACTURER CONCLUDES THE PT WAS NOT AS APPROPRIATE CANDIDATE FOR BIPAP THERAPY AND THAT DEVICE LABELING IS ADEQUATE TO SUPPORT THE INTENDED USE OF BIPAP DEVICES. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH REPORT ((B)(4)) ALLEGING A PT EXPIRED WHEN SHE BECAME DISCONNECTED FROM A BIPAP DEVICE (MODEL UNK). THE PT WAS REPORTED TO HAVE BECOME DISCONNECTED FROM THE DEVICE DURING THE NIGHT AND WAS FOUND TO BE UNRESPONSIVE AND PULSELESS THE NEXT MORNING. THE PT HAD "DO NOT RESUSCITATE" STATUS AND NO EMERGENCY MEASURES WERE TAKEN. THE REPORTER OF THE EVENT ALLEGES THE BIPAP DEVICE DID NOT AUDIBLY ALARM TO ALERT THE CAREGIVER OF THE PT DISCONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP DEVICE NONE BZD RESPIRONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PERFORMATRAK MASK, PART NUMBER 1012624| TUBING