BEUDAMED
    FDA Adverse Event Other Summary report: N

    VPAP S

    MDR report key: 2550409 · Received April 20, 2012

    Report

    Report Number
    3004604967-2012-00016
    Event Type
    Other
    Date Received
    April 20, 2012
    Date of Event
    March 1, 2012
    Report Date
    April 20, 2012
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K080131
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR. RESMED HAS REQUESTED THE DEVICE BE RETURNED SO AN ENGINEERING INVESTIGATION CAN BE PERFORMED. THE RPTR STATED THEY SPOKE WITH THE PT ON THE DAY OF THE OCCURRENCE AND DID NOT NOTICE ANY SHORTNESS OF BREATH OR OTHER PHYSICAL ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR THAT A PT USING A RESMED DEVICE HEARD A HIGH PITCHED NOISE THEN SMELLED BURNT PLASTIC COMING FROM THEIR VPAP UNIT. THE PT THEN REPORTED HAVING A HEADACHE AND SHORTNESS OF BREATH WHICH LED THEM TO SEEK MEDICAL ATTENTION. THE PT WENT TO THE EMERGENCY ROOM AND HAD CHEST X-RAYS AND BLOOD WORK TESTS PERFORMED. IT WAS STATED THEY HAD THEIR OXYGEN LEVEL MEASURE IN THE LOW 80'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPAP S BZD RESMED LTD 2611902

    Patients

    Seq Age Sex Outcome Treatment
    1 Other OXYGEN