BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 19149901 · Received April 20, 2024

    Report

    Report Number
    2518422-2024-16250
    Event Type
    Malfunction
    Date Received
    April 20, 2024
    Date of Event
    March 4, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K200480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW-5152518) IN WHICH THE PATIENT ALLEGES THAT HAVE BEEN BURNING SMELL AND THE TANK DRIES UP BEFORE THE END OF EACH NIGHT. MEDICAL INTERVENTION WAS NOT INCLUDED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695011 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown