BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTO BIFLEX

    MDR report key: 24049730 · Received January 12, 2026

    Report

    Report Number
    2518422-2026-100098
    Event Type
    Malfunction
    Date Received
    January 12, 2026
    Date of Event
    September 27, 2024
    Report Date
    March 26, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959006010
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER REPORTED ON THIS DEVICE IN MDR 2518422-2026-100098 IN ERROR. AT THIS TIME OF INVESTIGATION, IT HAS BEEN DETERMINED THAT ALL FURTHER REPORTING ACTIVITIES WILL BE CARRIED OUT IN SRC (B)(4). SO, MDR 2518422-2026-100098 IS A DUPLICATE OF SRC (B)(4) MDR 2518422-2024-102810.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE PATIENT ALLEGES VISUALIZATION OF PARTICLES. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE THIRD PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION, THE DEVICE WAS VISUALLY INSPECTED AND NO VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, THE DUST WAS FOUND AND THE DEVICE WAS SCRAPPED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110342 BIPAP AUTO BIFLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS760HS 00606959006010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown