BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP AUTOSV ADV

    MDR report key: 19989228 · Received August 15, 2024

    Report

    Report Number
    2518422-2024-51569
    Event Type
    Death
    Date Received
    August 15, 2024
    Date of Event
    August 16, 2023
    Report Date
    July 11, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959012516
    PMA / PMN Number
    K090539
    Removal / Correction Number
    Z-1973-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN PREVIOUS REPORT DESCRIBE EVENT OR PROBLEM WAS CAPTURED INCORRECTLY AND IT HAS BEEN CORRECTED IN THIS REPORT. 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 AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED DEATH, PLEURAL EFFUSION, E COLI PNEUMONIA, ACUTE RESPIRATORY FAILURE, ACUTE BLOOD LOSS ANEMIA, BROKEN ARM, HOSPITALIZATION AND NURSING HOME. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, DUST WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. THERE WAS NO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED. IN BOX B: DATE OF DEATH CAPTURED. IN BOX D: DEVICE SERVICED BY 3RDP? AND DEVICE AVAILABLE FOR EVAL? HAS BEEN UPDATED. IN BOX G: DATE RECEIVED BY MFG, REPORT TYPE AND IN BOX H, IF FOLLOW-UP, WHAT TYPE?, DEVICE PROBLEM CODE GRID, EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, CONCLUSION CODE GRID, REMEDIAL ACTION INITIATED AND RECALL (Z) NUMBER HAS BEEN UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THAT THE PATIENT HAS PASSED AWAY. 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
    1163284 BIPAP AUTOSV ADV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DS960S 00606959012516

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death