BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR AUTO A-FLE

    MDR report key: 24490150 · Received March 2, 2026

    Report

    Report Number
    2518422-2026-007424
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    May 23, 2025
    Report Date
    March 2, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959069312
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    A REMSTAR AUTO A-FLEX DEVICE WAS RETURNED TO THE 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. THERE WAS NO INITIAL ALLEGED COMPLAINT FOUND. 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. ADDITIONALLY, THE SERVICE TECHNICIAN NOTED NO DUST CONTAMINATION. THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552798 REMSTAR AUTO A-FLE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. IN561S 00606959069312

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown