BEUDAMED
    FDA Adverse Event Other Summary report: N

    ELITE - AMERICAS

    MDR report key: 2577615 · Received May 1, 2012

    Report

    Report Number
    3004604967-2012-00018
    Event Type
    Other
    Date Received
    May 1, 2012
    Date of Event
    March 1, 2012
    Report Date
    May 1, 2012
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K091947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS NOT RETURNED TO THE MANUFACTURER AND IS NOT REPORTED TO HAVE MALFUNCTIONED. ON APRIL 2, 2012 RESMED'S CLINICAL SPECIALIST WAS MADE AWARE OF A PT BEING TREATED WITH AN S9 ELITE DEVICE REQUIRING RESUSCITATION. THE S9 ELITE IS DESIGNED FOR THE TREATMENT OF "OBSTRUCTIVE" SLEEP APNEA (OSA). THE CLINICAL SPECIALIST REVIEWED THE PT DATA AND FOUND INDICATION OF POTENTIAL "CENTRAL" SLEEP APNEA (CSA). BASED ON THIS INFO, RESMED REQUESTED THE REPORTER CONTACT THE DIAGNOSING PHYSICIAN TO REVIEW THE PT'S THERAPY AND THEIR PRESCRIBED DEVICE. ON APRIL 20, 2012 RESMED FOLLOWED-UP WITH THE REPORTER AND WAS INFORMED THAT THE PT'S NEUROLOGIST AGREED THAT THE PT MAY HAVE CSA ISSUES AND ORDERED ANOTHER SLEEP STUDY PERFORMED. THE SLEEP STUDY WAS PERFORMED AND THE PT WAS PRESCRIBED ANOTHER DEVICE TO TREAT THEIR SPECIFIC SLEEPING DISORDER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PT USING AN S9 ELITE DEVICE REQUIRED RESUSCITATION AND WAS HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELITE - AMERICAS BZD RESMED LTD. 36003

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L