BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM ONE REMSTAR AUTO A-FLEX BIPAP MACHINE

    MDR report key: 14644821 · Received June 8, 2022

    Report

    Report Number
    MW5110225
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 7, 2022
    Manufacturer
    VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE ONE OF THE RECALLED PHILIPS BIPAP MACHINES. I HAVE DIAGNOSED MODERATE (I THINK) SLEEP APNEA. HAVE BEEN USING THE MACHINE FOR ABOUT 15 YEARS. HAVE BEEN DIAGNOSED WITH ASTHMA, AS WELL. HAVE HAD SEVERAL SINUS INFECTIONS THAT I BELIEVE ARE RELATED TO THE USE OF THE MACHINE, THE LATEST BEING LAST MONTH MAY 2022. THERE HAVE ALSO BEEN PLENTY OF TIMES I HAVE WOKEN UP AFTER USING THE MACHINE WHERE MY LUNGS AND SINUSES, AND EVEN SOMETIMES MY EARS AND EYES HAVE FELT STUFFY AND INFLAMED. NEVER RECEIVED A SINGLE NOTICE FROM PHILIPS ABOUT THE RECALL, HAD TO LEARN ABOUT IT ON THE LOCAL NEWS IN MY CITY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23337 SYSTEM ONE REMSTAR AUTO A-FLEX BIPAP MACHINE PHILIPS RESPIRONICS / RESPIRONICS, INC. BZD VENTILATOR, NON-CONTINUOUS (RESPIRATOR) IP22 12 V / 6.67 A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Disability ADDERALL XR| BIPAP MACHINE| FLUOXETINE| IRON| PROBIOTIC| VITAMIN D