BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTO BIFLEX

    MDR report key: 23882336 · Received December 23, 2025

    Report

    Report Number
    2518422-2025-113040
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    December 17, 2025
    Report Date
    February 25, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959006027
    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

    MDR 2518422-2022-64666 IS THE ORIGINAL REPORT ASSOCIATED WITH THIS DEVICE. A DUPLICATE REPORT HAS BEEN SUBMITTED FOR THIS DEVICE UNDER REPORT MDR 2518422-2025-113040. THIS FOLLOW UP REPORT IS BEING FILED FOR AWARENESS OF THIS DUPLICATE REPORT.

    Additional Manufacturer Narrative · 0

    MDR 2518422-2025-113040 IS THE ORIGINAL REPORT ASSOCIATED WITH THIS DEVICE. A DUPLICATE REPORT HAS BEEN SUBMITTED FOR THIS DEVICE UNDER REPORT MDR 2518422-2022-64666. THIS FOLLOW UP REPORT IS BEING FILED FOR AWARENESS OF THIS DUPLICATE REPORT.

    Description of Event or Problem · 0

    THIS NOTIFICATION WAS OPENED FOR REVIEW OF INFORMATION RECEIVED THAT THE BIPAP AUTO BIFLEX 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 BIPAP DEVICES. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM PARTICLES OR DEGRADATION INSIDE THE BLOWER KIT. IN ADDITION, THE DEVICE HAD DUST/DIRT CONTAMINATION AND DISPLAYED ERROR CODE E053 (COMP LOG SEM TIMEOUT). THE DEVICE WAS SCRAPPED BY THE SERVICE CENTER AFTER THE EVALUATION WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1919971 BIPAP AUTO BIFLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS760TS 00606959006027

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown