BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLE

    MDR report key: 23602862 · Received November 20, 2025

    Report

    Report Number
    2518422-2025-053713
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    February 18, 2024
    Report Date
    November 20, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959024175
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED AS PART OF A BATCH SUBMISSION OF COMPLAINTS DEEMED REPORTABLE FOLLOWING RECORD CORRECTION AND REMEDIATION EFFORTS.

    Description of Event or Problem · 0

    A DEVICE WAS RETURNED TO A 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. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, DUST CONTAMINATION WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS ZERO ERRORS CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THERE WAS VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2661306 REMSTAR AUTO A-FLE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS560BT 00606959024175

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown