BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIPAP AUTOSV ADV

    MDR report key: 14337195 · Received May 9, 2022

    Report

    Report Number
    2518422-2022-18188
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 20, 2022
    Report Date
    July 30, 2024
    Manufacturer
    RESPORINOC INC
    Product Code
    MNS
    UDI-DI
    00606959012523
    PMA / PMN Number
    K090539
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY SUBMITTED MDR 2518422-2022-18188-1 .

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. ADDITIONAL INFORMATION WAS RECEIVED AND SECTION B5 SHOULD BE REPORTED AS: THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUNDABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED BEING DIAGNOSED WITH BLADDER CANCER WHILE USING THE DEVICE. THERE WAS NO MEDICAL INTERVENTION REQUIRED BY THE PATIENT. THIS NOTIFICATION WAS REVIEWED BY THE PMS CLINICAL EXPERT DUE TO THE PATIENT REPORTING BLADDER CANCER. THERE WAS NO EVIDENCE SUPPORTING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE ABOVE-MENTIONED SERIOUS INJURY. SMOKING IS A PRIMARY RISK FACTOR FOR A DIAGNOSIS OF BLADDER CANCER. THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED. SECTION(S) B1, B2, HAS CHANGED RELATED TO THE COMPLAINT CHANGING FROM THE REPORTED ADVERSE EVENT TO A PRODUCT PROBLEM. SECTION H1 HAS CHANGED TO REFLECT A MALFUNCTION. SECTION H6 HEALTH EFFECT- IMPACT CODE, TYPE OF INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS HAS BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON OCT 09, 2023, AND SECTION H11 SHOULD BE REPORTED AS: 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 ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED BEING DIAGNOSED WITH BLADDER CANCER WHILE USING THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED ALLEGATION OF DIZZINESS AND/OR HEADACHE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. SECTION B1 WAS CORRECTED TO PRODUCT PROBLEM. SECTION H1 WAS CHANGED FROM SERIOUS INJURY TO MALFUNCTION. SECTION H6 HEALTH EFFECTS - CLINICAL CODES AND HEALTH EFFECTS - IMPACT CODE WERE CORRECTED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED BEING DIAGNOSED WITH BLADDER CANCER WHILE USING THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    1460155 BIPAP AUTOSV ADV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPORINOC INC DS960HS 00606959012523

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other