BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR BIPAP AUTO M SERIES

    MDR report key: 4643426 · Received March 23, 2015

    Report

    Report Number
    MW5041698
    Event Type
    Injury
    Date Received
    March 23, 2015
    Date of Event
    January 15, 2015
    Report Date
    March 23, 2015
    Manufacturer
    RESPIRONICS
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    WHILE USING MY RESPIRONICS MODEL 1051158, I BEGAN TO SMELL SMOKE IN MY MASK. AS A RESULT, I IMMEDIATELY DISCONTINUED USING MY PAP DEVICE. I DON'T KNOW HOW LONG I INHALED THE SMOKE, AND I DON'T KNOW WHETHER THESE FUMES WERE HARMFUL TO ME. SINCE I AM UNABLE TO USE MY DEVICE, I AM NOW EXPERIENCING BAD SIDE EFFECTS, INCLUDING DAYTIME SOMNOLENCE THAT MY DEVICE WAS PREVIOUSLY ABLE TO PREVENT. I BELIEVE IT IS DANGEROUS FOR ME TO CONTINUE NOT USING THE DEVICE, BUT AM AFRAID THAT THE DEVICE WILL CONTINUE TO PRODUCE SMOKE, AND POSSIBLY FIRE. IT IS NOT DIFFICULT TO FIND NUMEROUS COMPLAINTS (INCLUDING IN MAUDE) ABOUT THIS PRODUCT WHICH ARE SIMILAR TO MY COMPLAINT. IN FACT, RESPIRONICS HAS ISSUED A RECALL FOR THE HUMIDIFIER UNIT IN THIS PAP DEVICE. HOWEVER, WHEN CONTACTED, RESPIRONICS INSISTS THAT THE SERIAL NUMBER OF MY UNIT ((B)(4)) IS NOT INCLUDED IN THE RECALL. THIS IN SPITE OF THE FACT THAT MY UNIT IS OF THE SAME MODEL AS THE MODEL IN THEIR RECALL, AND IS EXPERIENCING THE VERY PROBLEM FOR WHICH THE RECALL WAS ISSUED. I BELIEVE THAT THE DEFECT IN MY RESPIRONICS DEVICE POSES A SERIOUS DANGER TO MY HEALTH AND PROPERTY. I BELIEVE THAT THE RESPIRONICS RECALL SHOULD BE EXPANDED TO INCLUDE ADDITIONAL SERIAL NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193790 REMSTAR BIPAP AUTO M SERIES REMSTAR BIPAP AUTO M SERIES BZD RESPIRONICS 1051158

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention