BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLEX

    MDR report key: 24189049 · Received January 27, 2026

    Report

    Report Number
    2518422-2026-003303
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 22, 2026
    Report Date
    January 27, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZS
    UDI-DI
    00606959012790
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A REMSTAR AUTOA-FLEX DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED, AND EVIDENCE OF BLOWER FOAM DEGRADATION WAS FOUND. ADDITIONALLY, THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252369 REMSTAR AUTO A-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZS RESPIRONICS, INC. DS250S 00606959012790

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown