BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PLUS

    MDR report key: 23990519 · Received January 7, 2026

    Report

    Report Number
    2518422-2026-000637
    Event Type
    Malfunction
    Date Received
    January 7, 2026
    Date of Event
    December 28, 2025
    Report Date
    March 19, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005778
    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

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

    Description of Event or Problem · 0

    A REMSTAR PLUS DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR SERVICE AS PART OF THE SOUND ABATEMENT FOAM RECALL PROCESS WITH NO INITIAL ALLEGED COMPLAINT. DURING THE EVALUATION OF THE DEVICE AT THE THIRD PARTY SERVICE CENTER THE FOAM PARTICLES WERE FOUND INSIDE THE BLOWER KIT AND AN OBJECT CODE INDICATES THE BLOWER CONTRIBUTING TO THE FOAM DEGRADATION WAS NOTED. ADDITIONALLY, THE SERVICE TECHNICIAN ALSO OBSERVED AN ERROR CODE E20 (ERR_MOTOR_SPINUP_FLUX) ON THE DEVICE LOGS. THERE WAS ALSO A DUST OR DIRT CONTAMINATION PRESENT IN THE DEVICE. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED. THE 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
    54344 REMSTAR PLUS VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS260HS 00606959005778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown