BEUDAMED
    FDA Adverse Event Other Summary report: N

    S9 ESCAPE - AMERICAS

    MDR report key: 2543138 · Received March 30, 2012

    Report

    Report Number
    3004604967-2012-00011
    Event Type
    Other
    Date Received
    March 30, 2012
    Date of Event
    January 1, 2012
    Report Date
    March 30, 2012
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K111148
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DME REPORTED THE PT'S OXYGEN LEVEL DROPPED SIGNIFICANTLY. A PRELIMINARY INVESTIGATION OF THE DEVICE HAS BEEN PERFORMED AT RESMED. THE DEVICE USAGE LOG WAS DOWNLOADED AND CONFIRMED UNIT SHUT OFF IN THE NIGHT. A VISUAL INSPECTION OF THE DEVICE IDENTIFIED AN EXCESSIVE AMOUNT OF HOUSEHOLD DUST AND HAIR. THE DME REPORTED THERE WAS A STORM THAT NIGHT THAT MAY HAVE KNOCKED OUT POWER. EITHER OF THESE CONDITIONS WILL LIKELY RESULT IN THE FAILURE OF THE DEVICE. IT IS UNK IF THE PT HAD ANY OTHER PRE-EXISTING MEDICAL CONDITIONS. PT IS CURRENTLY OUT OF THE HOSP AND DOING WELL. THE DEVICE IS BEING SENT TO THE (B)(4) FOR A FULL ENGINEERING INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PT USING A S9 ESCAPE DEVICE WITH SUPPLEMENTAL OXYGEN WAS FOUND UNCONSCIOUS AND TAKEN TO THE HOSP. THE S9 DEVICE WAS ALLEGED TO HAVE STOPPED WORKING DURING THE NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S9 ESCAPE - AMERICAS BZD RESMED LTD. 36001

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening