BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMFORTGEL FULL FACEMASK WITH HEADGEAR

    MDR report key: 1749725 · Received July 7, 2010

    Report

    Report Number
    2518422-2010-00049
    Event Type
    Death
    Date Received
    July 7, 2010
    Date of Event
    May 15, 2010
    Report Date
    June 7, 2010
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K073600
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL INFO FROM THE MFR OF THE CPAP AND TUBING INDICATED THE CHILD WAS USING A RESPIRONICS, INC. COMFORT GEL FULL FACEMASK. THE DURABLE MEDICAL EQUIPMENT (DME) SUPPLIER WHO FURNISHED THE CPAP, TUBING, AND MASK CONFIRMED THE CHILD HAD TWO DIFFERENT STYLE MASKS AND IT HAS NOT BEEN VERIFIED WHICH MASK WAS IN USE AT THE TIME OF THE EVENT. PRODUCT LABELING FOR THE COMFORT GEL FULL FACEMASK (COMFORT GEL FULL INSTRUCTIONS FOR USE) STATES: "THE MASK IS TO BE USED ON PTS (B) (6) WHO ARE APPROPRIATE CANDIDATES FOR NONINVASIVE VENTILATION. THIS MASK SHOULD NOT BE USED FOR PTS WHO ARE UNCOOPERATIVE, OBTUNDED, UNRESPONSIVE, OR UNABLE TO REMOVE THE MASK." THE COMFORT GEL FULL FACEMASK DOES NOT HAVE SPECIFIC CLEARANCE FOR PEDIATRIC/CHILD USE. BASED ON ALL AVAILABLE INFO, PHILIPS RESPIRONICS CONCLUDES THE COMFORT GEL FULL FACEMASK WAS A CONCOMITANT DEVICE ASSOCIATED WITH THE REPORTED EVENT AND THAT THE MASK WAS BEING USED IN AN OFF-LABEL MANNER. NO FURTHER ACTION IS APPROPRIATE. THE MASK WAS NOT RETURNED TO THE MFR FOR EVAL.

    Description of Event or Problem · 1

    PHILIPS RESPIRONICS REC'D INFO FROM ANOTHER MEDICAL DEVICE MFR THAT A CHILD DIAGNOSED WITH CEREBRAL PALSY HAD EXPIRED AFTER BECOMING ENTANGLED WITH CIRCUIT TUBING THAT WAS IN USE WITH A CPAP DEVICE. THE MEDICAL MFR CONFIRMED THAT THEY WERE THE MANUFACTURERS OF THE CIRCUIT TUBING AND CPAP DEVICE, BUT THE MASK IN USE AT THE TIME OF THE EVENT IS BELIEVED TO BE MANUFACTURED BY PHILIPS RESPIRONICS. THE MEDICAL DEVICE MFR REPORTED THE CHILD WAS USING THE CPAP DEVICE WHILE UNATTENDED AND WAS DISCOVERED WITH THE TUBING WRAPPED AROUND HIS NECK. THE CPAP, TUBING AND MASK HAVE BEEN QUARANTINED BY THE SHERIFF'S DEPARTMENT IN (B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMFORTGEL FULL FACEMASK WITH HEADGEAR VENTILATOR NON-CONTINUOUS RESPIRATOR BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death RESMED S8 AUTO II WITH TUBING