BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTOSV ADVANCED SYSTEM

    MDR report key: 13389170 · Received January 28, 2022

    Report

    Report Number
    2518422-2022-02597
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    December 29, 2021
    Report Date
    September 30, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 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.  A CORRECTION TO B5 WAS MADE AND SHOULD BE:  THE MANUFACTURER RECEIVED INFORMATION ALLEGING VISUALIZATION OF PARTICLES RELATED TO A BIPAP AUTOSV DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. HE STATED THAT I DO NOT RECALL SENDING IN A COMPLAINT. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.  SECTION D2 CORRECTED AS PRODUCT CODE: MNS, D4 UDI NUMBER WRONGLY TAKEN, G4 CORRECTED PMA/510(K):K090539 AND H6 UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM/INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150476 BIPAP AUTOSV ADVANCED SYSTEM VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DS950S
    1510654 BIPAP AUTOSV ADVANCED SYSTEM VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DS950S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown