BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 21735680 · Received March 31, 2025

    Report

    Report Number
    2518422-2025-040475
    Event Type
    Malfunction
    Date Received
    March 31, 2025
    Date of Event
    March 22, 2024
    Report Date
    June 18, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959062740
    PMA / PMN Number
    K131982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION REPORTED WITH MDR 2518422-2025-040475 IS CONSIDERED AS NOT REPORTABLE. IN THIS REPORT A CORRECTION HAS BEEN MADE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING RESPIRATORY ISSUE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. 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
    1041302 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520T11C 00606959062740

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male