BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION 2 AUTO CPAP ADVANCED

    MDR report key: 18383815 · Received December 21, 2023

    Report

    Report Number
    MW5149468
    Event Type
    Malfunction
    Date Received
    December 21, 2023
    Date of Event
    November 22, 2023
    Report Date
    December 19, 2023
    Manufacturer
    PHILIPS / RESPIRONICS INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    TICKET NUMBER WITH PHILIPS RESPIRONICS: (B)(4) PATIENT'S CONTINUOUS POSITIVE AIRWAY PRESSURE ON/OFF BUTTON DOES NOT SHUT DOWN UNIT. PATIENT NOTIFICATIONS TO PHILIPS ARE NOT BEING RESOLVED. PATIENT HAS BEEN OVER ONE MONTH WITHOUT UNDER WARRANTY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263956 DREAMSTATION 2 AUTO CPAP ADVANCED VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS INC. DSX520H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other