BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REP DREAMSTATION AVAPS30

    MDR report key: 23953570 · Received January 3, 2026

    Report

    Report Number
    2518422-2026-000254
    Event Type
    Malfunction
    Date Received
    January 3, 2026
    Date of Event
    December 21, 2025
    Report Date
    May 27, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959063457
    PMA / PMN Number
    K102465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING MELTING OF THE POWER PORT ON A DREAMSTATION AVAPS30. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41845 REP DREAMSTATION AVAPS30 VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX1130S11F 00606959063457

    Patients

    Seq Age Sex Outcome Treatment
    1