BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT LT FOR HER MASK SYS - USA

    MDR report key: 1935341 · Received December 15, 2010

    Report

    Report Number
    3004604967-2010-00046
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    October 15, 2010
    Report Date
    December 14, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K073638
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED WAS INFORMED THAT A PATIENT WEARING A CPAP NASAL PILLOW MASK HAD A NOSE BLEED THAT WOULD NOT STOP. THE PATIENT THEN WENT TO THE EMERGENCY ROOM WHERE SHE WAS REPORTED TO HAVE A RUPTURED SINUS CAVITY. THE MASK WAS NOT RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION NOR IS THE MASK ALLEGED TO HAVE BEEN MALFUNCTIONING. WITH THE INFORMATION AVAILABLE RESMED'S CHIEF MEDICAL OFFICER PROVIDED THE FOLLOWING OPINION: "CPAP CAN AGGRAVATE PRE-EXISTING SINUS CONDITIONS AS THE PRESSURE MAY IMPEDE DRAINAGE AND CAUSE PAIN. IT IS POSSIBLE THAT CPAP AGGRAVATED A PRE-EXISTING CONDITION IN THIS PATIENT INVESTIGATION OF WHICH HAS REVEALED THE PRESENCE OF A FRACTURE OR SIMILAR ISSUE, BUT IT IS NOT PLAUSIBLE THAT THE DEVICE LED TO THE RUPTURE OF A NORMAL SINUS CAVITY."

    Description of Event or Problem · 1

    A PATIENT USING A CPAP MACHINE WENT TO THE EMERGENCY ROOM WHERE SHE WAS REPORTED TO HAVE A RUPTURED SINUS CAVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT LT FOR HER MASK SYS - USA BZD RESMED LTD. 60588

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RESPIRONICS FLOW GENERATOR SETUP ON (B)(4)-2010