BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPAP

    MDR report key: 18816006 · Received February 28, 2024

    Report

    Report Number
    MW5152210
    Event Type
    Malfunction
    Date Received
    February 28, 2024
    Date of Event
    February 24, 2024
    Report Date
    February 26, 2024
    Manufacturer
    PHILLIPS / RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UNIT DISPENSES HOT AIR OR GETS HOT ESPECIALLY IF UNIT NOT PERFECTLY LEVEL. HUMIDIFIER IS OFF. (B)(6) REPLACE PHILIPS RESPIRONICS DREAMSTATION 2 THEY ASKED ME TO SEND IN THE OLD ONE BUT I HAVEN'T SENT IT IN YET I MIGHT NEED TO USE IT AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695344 CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILLIPS / RESPIRONICS, INC. DS2

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male