BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS DREAMSTATION AUTO-CPAP

    MDR report key: 12032237 · Received June 17, 2021

    Report

    Report Number
    MW5101975
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    June 14, 2021
    Report Date
    June 15, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I OWN TWO PHILIPS DREAMSTATION AUTO-CPAP MACHINES, AND ONE DREAMSTATION GO AUTO-CPAP MACHINES. I HAVE SEVERE SLEEP APNEA AND REQUIRE THESE MACHINES TO AVOID A HEART ATTACK AND DEATH. I HAVE DISCOVERED TODAY THAT PHILIPS HAS DECIDED TO MAKE SOME KIND OF "LAZY RECALL" OF THESE DEFECTIVE DEVICES. THEY ANNOUNCED A RECALL BUT THERE IS NO WAY TO REGISTER THE DEFECTIVE MACHINE WITH THEM. (THIS IS STUPID ANYWAY; THE MACHINES GENERALLY REQUIRE USE OF THE PHILIPS DREAMMAPPER APP ON A COMPUTER OR IPHONE, AND THEY HAVE ALL THE OWNER REGISTRATION DETAILS ALREADY). IF THESE MACHINES ARE DANGEROUS AND BEING RECALLED I NEED MY MACHINES REPLACED. THE PHILIPS "PRESS RELEASE" SAYS "THE BENEFIT OF CONTINUED USAGE OF THESE THERAPY DEVICES MAY OUTWEIGH THE RISKS IDENTIFIED IN THE RECALL NOTIFICATION" IS ABSURD IN THE EXTREME. I'M SUPPOSED TO CHOOSE BETWEEN CANCER OR A HEART ATTACK? THIS IS BEING HORRIBLY HANDLED. TIME TO PROTECT THE CONSUMERS. THESE ARE MEDICAL DEVICES. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911198 PHILIPS DREAMSTATION AUTO-CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC.
    911199 PHILIPS DREAMSTATION AUTO-CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC.
    911200 DREAMSTATION GO AUTO-CPAP MACHINE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention