BEUDAMED
    FDA Adverse Event Death Summary report: N

    S8 ELITE - AMERICAS

    MDR report key: 999187 · Received February 14, 2008

    Report

    Report Number
    3004604967-2008-00001
    Event Type
    Death
    Date Received
    February 14, 2008
    Date of Event
    November 26, 2007
    Report Date
    February 12, 2008
    Manufacturer
    RESMED LTD.
    Product Code
    MNS
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER AN INITIAL AND INCONCLUSIVE INVESTIGATION OF THE DEVICE AT RESMED CORP., THE DEVICE WAS SENT TO RESMED LTD. (THE MANUFACTURER AND DESIGN HOUSE) FOR FURTHER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED WITHIN THE NEXT 30 DAYS.

    Description of Event or Problem · 1

    ON DECEMBER 4, 2007, RESMED BECAME AWARE OF THE DEATH OF A PATIENT IN ANOTHER COUNTRY WHO WAS A USER OF RESMED S8 ELITE FLOW GENERATOR. ACCORDING TO THE PATIENT'S WIFE, THE PATIENT SUFFERED A MAJOR CORONARY HEART ATTACK WHILE ON HIS WAY TO BED. THE PATIENT WAS A MALE, AND ACCORDING TO THE PATIENT'S WIFE, HAD SEVERE SLEEP APNEA, BUT NO KNOWN OTHER AILMENTS. ALTHOUGH THE PATIENT WAS NOT USING THE DEVICE AT THE TIME OF THE ADVERSE EVENT, THE PATIENT'S WIFE STATED DEVICE HAD NOT BEEN WORKING CORRECTLY WHEN THE PATIENT HAD BEEN USING IT FOR TREATMENT, AND THAT THE PATIENT HAD SAID TO HER THAT THE DEVICE WAS TURNING OFF DURING THE NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S8 ELITE - AMERICAS S8 ELITE - AMERICAS MNS RESMED LTD. 33021 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR