BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION 1

    MDR report key: 15550487 · Received October 5, 2022

    Report

    Report Number
    MW5112455
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    October 1, 2022
    Report Date
    October 3, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PHILIPS RESPIRONICS INC SENT ME A REFURBISHED DEVICE AS PART OF THE RECALL OF MY DREAMSTATION MACHINE. I AM SUFFERING FROM ANXIETY USING THIS DEVICE AS IT'S REFURBISHED. I DON'T KNOW WHAT'S NEW? WHERE IT'S BEEN USED? WHOSE HAD IT? HOW LONG IT WILL LAST? I AM CONCERNED OVER THE HYGIENE AND HOW CLEAN THE MACHINE IS. I WOULD LIKE A BRAND NEW DEVICE FOR PIECE OF MIND. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577019 DREAMSTATION 1 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DREAMSTATION 1

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male BENICAR METOPROLOL | CRESTOR| ZOLOFT