BEUDAMED
    FDA Adverse Event Death Summary report: N

    CPAP MACHINE DREAM STATION

    MDR report key: 18552007 · Received January 19, 2024

    Report

    Report Number
    MW5150577
    Event Type
    Death
    Date Received
    January 19, 2024
    Date of Event
    May 7, 2022
    Report Date
    January 18, 2024
    Manufacturer
    PHILIPS / RESPIRONICS INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY HUSBAND, (B)(6) (AGE 68) USED THE PHILIPS DREAM STATION CPAP MACHINE FOR ABOUT 2 YEARS BEFORE IT WAS RECALLED. HE WAS DIAGNOSED WITH NON-SMALL CELL LUNG CANCER WITH A 7.8 CM MASS AND DIED 6 MONTHS LATER. HE NEVER SMOKED. ON (B)(6) DEATH CERTIFICATE IT WAS STATED THAT HE HAD THE CANCER ABOUT 1 YEAR AT DEATH. IT TOOK HIM VERY FAST. MANUFACTURED 08/05/2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404045 CPAP MACHINE DREAM STATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death