BEUDAMED
    FDA Adverse Event Other Summary report: N

    S9 VPAP AUTO - AMERICAS

    MDR report key: 2979975 · Received February 20, 2013

    Report

    Report Number
    3004604967-2013-00003
    Event Type
    Other
    Date Received
    February 20, 2013
    Date of Event
    January 1, 2013
    Report Date
    February 20, 2013
    Manufacturer
    RESMED LTD.
    Product Code
    BZD
    PMA / PMN Number
    K102513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRELIMINARY EVALUATION OF THE RETURNED UNIT DID NOT SHOW ANY SIGNS OF DAMAGE OR DEGRADATION. THE DEVICE WAS FUNCTIONALLY TESTED AND FOUND TO BE OPERATING PROPERLY. A REVIEW OF THE ERROR LOGS STORED WITHIN THE DEVICE DID NOT SHOW ANY ERRORS INDICATIVE OF A PRESSURE SENSOR FAILURE THAT WOULD PRODUCE A PRESSURE SURGE. NO FAULT WAS FOUND WITH THE DEVICE. THE DEVICE WILL BE SENT TO THE DESIGN FACILITY IN (B)(4) FOR AN ENGINEERING EVALUATION. THE FOLLOWING INFORMATION IS INCLUDED IN THE RESMED S9 VPAP AUTO INFORMATION GUIDE: THE FOLLOWING SIDE EFFECTS MAY ARISE DURING THE COURSE OF THERAPY WITH THE DEVICE: DRYING OF THE NOSE, MOUTH, OR THROAT, NOSEBLEED, BLOATING, EAR OR SINUS DISCOMFORT, EYE IRRITATION, SKIN RASHES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A PT EXPERIENCED PRESSURE SURGES WHILE USING AN S9 DEVICE WHICH CAUSED A SEVERE NOSE BLEED. THE PT WENT TO THE EMERGENCY ROOM FOR CAUTERIZATION TO STOP THE NOSE BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74822 S9 VPAP AUTO - AMERICAS BZD RESMED LTD. 36006

    Patients

    Seq Age Sex Outcome Treatment
    1 Other