BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENSTAR PRO

    MDR report key: 384297 · Received February 19, 2002

    Report

    Report Number
    MW4003228
    Event Type
    Malfunction
    Date Received
    February 19, 2002
    Report Date
    February 19, 2002
    Manufacturer
    BIPAP RESPIRONICS INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT RECENTLY PURCHASED A VENTILATOR WITH A MASK TO TREAT SLEEP APNEA. CONSUMER USED IT ON TWO CONSECUTIVE NIGHTS AND FOUND IT TO HAVE A VERY STRONG CHEMICAL ODOR. CONSUMER THINKS THE ODOR MIGHT BE THE PLASTIC ODOR FROM THE PLASTIC TUBING. CONSUMER IS CONCERNED THAT BREATHING THIS ODOR EVERY NIGHT OVER TIME MIGHT POSSIBLY BE A HEALTH HAZARD. CONSUMER IS ALSO CONCERNED ABOUT THE LEVEL OF "PVC" THAT MIGHT BE IN THE PLASTIC. CONSUMER CALLED THE MFR AND WAS TOLD THAT THEY HAVE HEARD OF THIS TYPE OF COMPLAINT AND SUGGESTED THAT THEY LET THE VENTILATOR RUN FOR 24 HRS TO SEE IF THE ODOR WOULD DISSIPATE. CONSUMER WOULD LIKE TO SEE THE EXHAUST ANALYZED IN DETAIL AT VERY LOW LEVELS OF DETECTABILITY, SINCE UNLIKE 99% OF OTHER MEDICAL DEVICES, THIS UNIT FORCES ITS EXHAUST INTO THE PT'S LUNGS. ITS EXHAUST IS MEANT TO BE FORCED INTO THE PT'S LUNGS FOR 8 HRS PER DAY FOR THE REST OF THE PT'S LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENSTAR PRO CONTINUOUS POSITIVE AIR PRESSURE (C-PAP)-REMSTAR PRO DEVICE CBK BIPAP RESPIRONICS INC. 1005961 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *