BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHILIPS DREAMSTATION AUTO CPAP

    MDR report key: 12860879 · Received November 22, 2021

    Report

    Report Number
    MW5105505
    Event Type
    Death
    Date Received
    November 22, 2021
    Date of Event
    January 3, 2021
    Report Date
    November 18, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IN 2020, (B)(6) BEGAN SUFFERING WITH ADULT ONSET ASTHMA AND SEEING A PULMONOLOGIST WHO WAS CONCERNED ABOUT THE SEVERITY OF THE ASTHMA AND THE UNKNOWN CAUSE AND LATE ONSET OF THE ASTHMA. HE WAS RECEIVING ASTHMA INJECTIONS OF XOLAIR THAT WERE VERY EXPENSIVE AND NOT VERY EFFECTIVE. IN (B)(6) 2021, (B)(6) WAS DIAGNOSED WITH PANCREATIC CANCER. BOTH OF THESE CONDITIONS HAVE BEEN DISCUSSED IN THE RECALL OF THE PHILIPS CPAP MACHINE THAT HE HAD BEEN USING SINCE (B)(6) 2018. I AM CONCERNED THAT THE PHILIPS CPAP MACHINE MAY HAVE CONTRIBUTED TO HIS DEATH ON (B)(6) 2021. PASSED AWAY FROM PANCREATIC CANCER ON (B)(6) 2021. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1755817 PHILIPS DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC. DSX500T11

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other| D NONE - DECEASED