BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REP DREAMSTATION BIPAP

    MDR report key: 22071041 · Received May 22, 2025

    Report

    Report Number
    2518422-2025-105975
    Event Type
    Malfunction
    Date Received
    May 22, 2025
    Date of Event
    April 24, 2025
    Report Date
    May 22, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959063495
    PMA / PMN Number
    K090539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THIS NOTIFICATION WAS OPENED FOR REVIEW DUE TO AN ALLEGATION OF MALFUNCTIONING HUMIDIFIER, INCORRECT AIR PRESSURE, AND A REPLACEMENT DEVICE THAT WAS INEFFECTIVE ON A REP DREAMSTATION BIPAP DEVICE. ADDITIONALLY, THE PATIENT EXPERIENCED DISCOMFORT, SUCH AS A DRY THROAT AND MOUTH, WHICH REQUIRED MEDICAL INTERVENTION. BASED ON THE AVAILABLE INFORMATION, THERE IS ENOUGH EVIDENCE TO INDICATE THIS ISSUE IS REPORTABLE TO ANY REGULATORY AGENCIES. 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
    2367101 REP DREAMSTATION BIPAP VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900S11F 00606959063495

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female