BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOSPITAL FULL FACE MASK MED - CE

    MDR report key: 1656533 · Received April 7, 2010

    Report

    Report Number
    3004604967-2010-00016
    Event Type
    Injury
    Date Received
    April 7, 2010
    Date of Event
    March 8, 2010
    Report Date
    April 7, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K041362
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT WAS REPORTED TO (B) (4) UNDER FOLLOWING (B) (4). IT WAS REPORTED THAT DURING THE EVENT, THE PT BECAME CYANOTIC, HOWEVER, THE PT DID NOT SUFFER ANY PERMANENT INJURY. WITH THE INFO AVAILABLE, RESMED'S MEDICAL DIRECTOR PROVIDED THE FOLLOWING OPINION: "IT IS CERTAINLY POSSIBLE THAT THE CYANOSIS OBSERVED IN THIS PT WAS IN SOME PART DUE TO DISCONTINUATION OF THERAPY RATHER THAN THE POTENTIAL EFFECTS OF THE MASK AND HEADGEAR BEING TANGLED AROUND THEIR NECK. DESPITE NIV THERAPY BEING COMMONPLACE IN THE TREATMENT OF ACUTE RESPIRATORY FAILURE, I AM UNAWARE OF A SIMILAR CASE TO THIS. THERE IS NO PUBLISHED LITERATURE DESCRIBING A SIMILAR EVENT AND TO MY KNOWLEDGE NOTHING IN OUR COMPLAINTS DATABASE. IF A MASK CAN BE DISLODGED AND TWISTED SO TIGHTLY AS TO CAUSE HARM, IT MUST BE AN EXTREMELY RARE OCCURRENCE." THIS IS THE FIRST COMPLAINT RESMED HAS RECEIVED REGARDING A 'STRANGULATION THREAT'. THE DEVICE INVOLVED WAS NOT RETURNED TO RESMED AND NO QUALITY DEFECT IS ALLEGED. THE MANUFACTURER HAS COMMENCED AN INVESTIGATION WHICH WILL INVOLVE TESTING TO REPRODUCE THE FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED (B) (4) THAT A HOSPITAL PT PULLED THE FULL FACE MASK (FFM) OFF IN A DOWNWARDS DIRECTION AND THEN TWISTED THE MASK ONCE. THIS TIGHTENED THE HEADGEAR AROUND THEIR NECK POSING A STRANGULATION THREAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOSPITAL FULL FACE MASK MED - CE HOSPITAL FFM BZD RESMED LTD. 60701

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening