BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTOSV ADV

    MDR report key: 15743866 · Received November 7, 2022

    Report

    Report Number
    2518422-2022-91664
    Event Type
    Malfunction
    Date Received
    November 7, 2022
    Date of Event
    September 15, 2021
    Report Date
    March 30, 2023
    Manufacturer
    RESPIRONICS INC
    Product Code
    MNS
    UDI-DI
    00606959029798
    PMA / PMN Number
    K090539
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING BREATHING DIFFICULTY RELATED TO A BIPAP 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. 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. CORRECTED INFORMATION WAS PROVIDED IN G.4. (NOW CORRECTED AS K090539). ADDITIONAL INFORMATION WAS PROVIDED IN D1(PREVIOUSLEY REPORTED AS PHILIPS CPAP DEVICE), D2 AND D4 SECTIONS. H6 UPDATED IN THIS REPORT.

    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 MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE MANUFACTURER RECEIVED INFORMATION ALLEGING OF BREATHING DIFFICULTY. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2809212 BIPAP AUTOSV ADV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS INC DS960XHS 00606959029798
    2852929 BIPAP AUTOSV ADV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS INC DS960XHS 00606959029798

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown