BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILIPS RESPIRONICS CPAP RNTCPAP5

    MDR report key: 12294174 · Received August 6, 2021

    Report

    Report Number
    MW5103088
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    October 9, 2020
    Report Date
    August 4, 2021
    Manufacturer
    PHILIPS RESPIRONICS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BLOOD CANCER - MPN; THE PHILIPS RESPIRONICS CPAP DEVICE THAT I USED SINCE (B)(6) 2017 FOR SLEEP APNEA HAS ISSUED A RECALL, DUE TO POTENTIAL RISKS RELATED TO THE FOAM USED TO REDUCE THE SOUND AND VIBRATION OF THE MOTOR. ONE OF THE RISKS IS POTENTIAL CANCER CAUSED FROM THE TOXIC GASES. I WAS DIAGNOSED WITH MYELOPROLIFERATIVE NEOPLASM IN (B)(6) 2020. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188747 PHILIPS RESPIRONICS CPAP RNTCPAP5 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS RESPIRONICS / RESPIRONICS, INC. RNTCPAP DREAMSTATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other