BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PLUS

    MDR report key: 23956094 · Received January 5, 2026

    Report

    Report Number
    2518422-2026-000202
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 23, 2025
    Report Date
    March 19, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959030060
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP IS NECESSARY AS THE 510K UNDER REPORT INFORMATION SHOULD BE K131982 FOR REMSTAR AUTO 60 SERIES DEVICE.

    Description of Event or Problem · 0

    A REMSTAR PLUS DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER AS PART OF THE UNO RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING EVALUATION NO FOAM PARTICLES WERE NOTED IN THE AIRPATH, YET FOAM DEGRADATION WAS NOTED. THE DEVICES SOUND ABATEMENT FOAM (NEEDS) OR (WAS) REPLACED TO ADDRESS THE ISSUE. ALSO, A DUST CONTAMINATION WAS PRESENT ON THE DEVICE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17433 REMSTAR PLUS VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. CA261HS 00606959030060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown