BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP AUTOSV ADV

    MDR report key: 19780431 · Received July 19, 2024

    Report

    Report Number
    2518422-2024-45850
    Event Type
    Death
    Date Received
    July 19, 2024
    Date of Event
    March 6, 2023
    Report Date
    July 11, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959012530
    PMA / PMN Number
    K090248
    Removal / Correction Number
    Z-1973-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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. 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. 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: ADVERSE EVENT/PRODUCT PROBLEM UPDATED. IN BOX D: MODEL NUMBER, LOT # (RFB), CATALOG ITEM IDENTIFIER, EXPIRATION DATE (RFB) AND PRODUCT UDI CORRECTED. DEVICE SERVICED BY 3RDP?, DEVICE AVAILABLE FOR EVAL? HAS BEEN UPDATED. DATE RECEIVED BY MFG, REPORT TYPE, 510K 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 WAS CONTACTED IN REFERENCE TO A BIPAP AUTOSV ADV DEVICE. THE PATIENT 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
    1555982 BIPAP AUTOSV ADV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DS960TS 00606959012530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death