BEUDAMED
    FDA Adverse Event Death Summary report: N

    S8 AUTOSET II - AMERICAS

    MDR report key: 1730847 · Received June 18, 2010

    Report

    Report Number
    3004604967-2010-00022
    Event Type
    Death
    Date Received
    June 18, 2010
    Date of Event
    May 15, 2010
    Report Date
    June 17, 2010
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K071171
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN OFFICIAL CAUSE OF DEATH HAS NOT BEEN RELEASED FOR THIS EVENT. THE S8 AUTOSET II SELF ADJUSTING SLEEP APNEA SYSTEM IS INDICATED FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA (OSA) IN ADULT PTS. THIS IS THE FIRST REPORTED OCCURRENCE RESMED HAS REC'D OF A POTENTIAL ADVERSE EVENT INVOLVING THE AIR TUBING BEING WRAPPED AROUND A PT'S NECK. THE DEVICE INVOLVED IN THIS EVENT WAS STILL OPERATING WHEN THE PT WAS FOUND AND IS NOT ALLEGED TO BE FAULTY. THE DEVICE IS CURRENTLY BEING HELD BY THE LOCAL AUTHORITIES, THEREFORE, RESMED IS UNABLE TO EVALUATE THE DEVICE. IF THE AUTHORITIES RELEASE THE DEVICE, THEN RESMED WILL PERFORM AN ENGINEERING INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT DIED WHILE USING A RESMED S8 AUTOSET II DEVICE. THE AIR TUBING WAS ALLEGEDLY FOUND WRAPPED AROUND THE PT'S NECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S8 AUTOSET II - AMERICAS S8 AUTOSET II BZD RESMED LTD. 33129

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Death AUTOSET II WITH STANDARD 2M TUBING| IT WAS REPORTED THE PT WAS SETUP ON A RESMED S8| AND A RESPIRONICS FULL FACE GEL MASK