BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION

    MDR report key: 15054996 · Received July 18, 2022

    Report

    Report Number
    MW5110942
    Event Type
    Injury
    Date Received
    July 18, 2022
    Date of Event
    July 1, 2021
    Report Date
    July 14, 2022
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    HI, PHILIPS HAD A RECALL ON DEVICES THAT ARE AFFECTED, SINCE THEN I REGISTERED MY DEVICE WITH PHILIPS AND WAS ABLE TO PRIORITIZE THE PROCESS THROUGH THE WEBSITE. IT HAS BEEN OVER 8 MONTHS OR MORE SINCE I REGISTERED THE DEFECTIVE DEVICE. I CALL PHILIPS AND ALL THEY SAY IS WE HAVE NO INFORMATION FOR YOU. I AM 59 YEARS OLD WITH A VERY BAD CASE OF SLEEP APNEA. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668089 DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Life Threatening