BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIRAGE SWIFT II MASK SYS - USA

    MDR report key: 1587041 · Received January 14, 2010

    Report

    Report Number
    3004604967-2010-00003
    Event Type
    Injury
    Date Received
    January 14, 2010
    Date of Event
    December 9, 2009
    Report Date
    January 14, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K042403
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED TO RESMED THAT THE MASK INVOLVED IN THIS EVENT WAS CLEANED BY THE SLEEP LAB USING CONTROL III DISINFECTANT SOLUTION. RESMED HAS NOT VALIDATED OR LABELED THE USE OF THIS DISINFECTANT WITH THIS MASK SYSTEM. IN ADDITION, THE PHYSICIAN REPORT STATES THAT THE MASK WAS WIPED DOWN WITH A CLEANER AND THEN PLACED ON THE PT'S FACE WHILE STILL DAMP. THE PT WOKE IN THE MORNING WITH A BURNING SENSATION ON THEIR FACE. AT THIS STAGE, WITH THE INFO AVAILABLE, THE EXACT CAUSE OF THE INJURY HAS NOT BEEN DETERMINED. RESMED HAS REQUESTED THE MASK SYSTEM BE RETURNED, SO A THOROUGH EVAL CAN BE PERFORMED.

    Description of Event or Problem · 1

    A SLEEP LAB REPORTED TO RESMED THAT ONE OF THEIR PTS OBTAINED A 2ND DEGREE CHEMICAL BURN ON THEIR FACE FROM THEIR CPAP MASK HEADGEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRAGE SWIFT II MASK SYS - USA MIRAGE SWIFT II BZD RESMED LTD. 60512 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR