BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR

    MDR report key: 23950026 · Received January 2, 2026

    Report

    Report Number
    2518422-2026-000176
    Event Type
    Malfunction
    Date Received
    January 2, 2026
    Date of Event
    December 23, 2025
    Report Date
    March 19, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959004979
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP IS NECESSARY AS THE 510K UNDER REPORT INFORMATION SHOULD BE K091319 FOR REMSTAR 50 SERIES DEVICE.

    Description of Event or Problem · 0

    A REMSTAR DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WAS NO INITIAL ALLEGED COMPLAINT FOUND. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES AND BLOWER FOAM DEGRADATION. THE SERVICE TECHNICIAN OBSERVED THAT ERROR CODE E063 (E-63: ERR_STUCK_KNOB_KEY) WAS PRESENT. IN ADDITION, THERE WAS CONTAMINATION FROM DUST. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. THIS EVENT IS REPORTABLE UNDER FDA 21 CFR PART 803 AS IT MEETS THE CRITERIA FOR A SERIOUS INJURY AND/OR PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12182 REMSTAR VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 00606959004979

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown