BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR SYSTEM ONE 60 SERIES

    MDR report key: 24107207 · Received January 19, 2026

    Report

    Report Number
    2518422-2026-000263
    Event Type
    Malfunction
    Date Received
    January 19, 2026
    Date of Event
    December 23, 2025
    Report Date
    March 19, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005761
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    510K HAS BEEN UPDATED TO K131982.

    Description of Event or Problem · 0

    THE REMSTAR PLUS, SYS ONE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF VISIBLE FOAM DEGRADATION INSIDE THE BLOWER KIT. A DUST FAIL CONTAMINATION WAS ALSO FOUND. IN ADDITION, THE DEVICE DISPLAYED ERROR CODES E062 (ERR_STUCK_RAMP_KEY), E066 (ERR_STUCK_ENCODER_B), E063 (ERR_STUCK_KNOB_KEY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169722 REMSTAR SYSTEM ONE 60 SERIES VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS260S 00606959005761

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown