BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP AUTO M-SERIES

    MDR report key: 2660767 · Received July 11, 2012

    Report

    Report Number
    2518422-2012-01384
    Event Type
    Death
    Date Received
    July 11, 2012
    Date of Event
    February 11, 2010
    Report Date
    June 13, 2012
    Manufacturer
    RESPIRONICS, INC
    Product Code
    BZD
    PMA / PMN Number
    K061034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE FILED WHEN ADDITIONAL INFO BECOMES AVAILABLE. ADDITIONAL INFO: K050759.

    Description of Event or Problem · 1

    A DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) REPORTED THAT A MUSCULAR DYSTROPHY PT DIED WHILE ON A BILEVEL POSITIVE AIRWAY PRESSURE DEVICE (BIPAP). DME ALLEGES THE MASK OR THE TUBING MAY HAVE BEEN DISPLACED OR DETACHED DURING THE NIGHT. IN ADDITION, DME ALLEGES THE DECEDENT'S PARENTS DID NOT HEAR ANY ALARM SOUND ON THE DEVICE WHEN THE BREATHING WAS INTERRUPTED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVAL. THE DEVICE IS NOT INTENDED FOR LIFE-SUPPORT OR DESIGNED TO PROVIDE VENTILATION WITH A GUARANTEED TIDAL VOLUME OR ALARMS. ACCORDING TO PT LABELING, THE INTENDED USE OF THE DEVICE IS ONLY FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA (OSA) IN SPONTANEOUSLY BREATHING PTS WEIGHING MORE THAN 66 POUNDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP AUTO M-SERIES VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC DS700S

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death