BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTOSV ADV

    MDR report key: 24586227 · Received March 12, 2026

    Report

    Report Number
    2518422-2026-009291
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    March 8, 2026
    Report Date
    March 16, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959014237
    PMA / PMN Number
    K090539
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE PREVIOUS REPORT. IN PREVIOUS REPORT THE 510K NUMBER WAS WRONG. IT SHOULD BE K090539. MANDATORY SECTION HAS BEEN UPDATED/CORRECTED.

    Description of Event or Problem · 0

    A BIPAP AUTOSV ADV DEVICE WAS RETURNED TO THE 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, THE SERVICE TECHNICIAN OBSERVED VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT. ADDITIONALLY, THE SERVICE TECHNICIAN FOUND DUST CONTAMINATION AND THE EVALUATION OF THE DEVICE DATA IDENTIFIED UNRELATED ERROR CODES. THESE ERROR CODES ARE CONSISTENT WITH NORMAL DEVICE OPERATION AND EXPECTED USE CONDITIONS AND ARE NOT CONSIDERED REPORTABLE UNDER MEDICAL DEVICE REPORTING REQUIREMENTS. NO EVIDENCE WAS IDENTIFIED TO SUGGEST THAT THESE ERROR CODES CONTRIBUTED TO OR CAUSED THE REPORTED EVENT. FURTHERMORE, THE UNIT WAS SCRAPPED UPON COMPLETION OF THE DEVICE EVALUATION. 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
    647999 BIPAP AUTOSV ADV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. CA961TS 00606959014237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown