BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO

    MDR report key: 23966983 · Received January 5, 2026

    Report

    Report Number
    2518422-2026-000393
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 28, 2025
    Report Date
    March 12, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005907
    PMA / PMN Number
    K131982
    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

    IN THE PREVIOUS REPORT, THE COMPLETE STATUS ON THE GENERAL INFORMATION TAB AND THE REPORT SOURCE IN BOX G WERE ENTERED INCORRECTLY, AND IN THIS REPORT BOTH FIELDS HAVE BEEN CORRECTED.

    Description of Event or Problem · 0

    A REMSTAR AUTO DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER AS PART OF THE UNO RECALL PROCESS 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 FOAM DEGRADATION/PARTICLES WAS FOUND INSIDE THE BLOWER KIT. ADDITIONALLY, THE DEVICE HAD DUST FAIL CONTAMINATION AND DISPLAYED ERROR CODE E041 (ERR STORAGE UNIT NVRAM) AND E057 (ERR SESS OBS QUEUE OVF). THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335763 REMSTAR AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS560TS 00606959005907

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown