BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 19028263 · Received April 2, 2024

    Report

    Report Number
    2518422-2024-16228
    Event Type
    Malfunction
    Date Received
    April 2, 2024
    Date of Event
    March 27, 2024
    Report Date
    June 17, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K200480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    MADE CORRECTION TO PROBLEM CODE GRID.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW-5151429)IN WHICH THE PATIENT ALLEGES THAT THE RESERVOIR TANK WATER FOR HUMIDIFICATION NEEDS TO BE REPLACED AT LEAST EVERY 2 DAYS AND WHEN IT RUNS DRY A VERY STRONG ODOR EMIT TO THE EXTENT PATIENT WAKES UP FROM A SOUND SLEEP. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    1782996 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown