BEUDAMED
    FDA Adverse Event Death Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 18462088 · Received January 8, 2024

    Report

    Report Number
    2518422-2024-01087
    Event Type
    Death
    Date Received
    January 8, 2024
    Date of Event
    December 13, 2023
    Report Date
    August 29, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION FROM THE FOLLOW-UP REPORT #2518422-2024-01087-1 HAS BEEN UPDATED TO THIS REPORT. THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A DREAMSTATION AUTO CPAP UNIT. THE DEVICE WAS REPORTED AS PART OF RECALL ACTIONS WITH NO INITIAL COMPLAINT ON THE DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING PATIENT HAS PASSED AWAY. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. CORRECTION TO PREVIOUS REPORT THAT THIS DEVICE WAS PART OF THE RECALL. AFTER EVALUATION, NO PARTICLE ALLEGATION, NO MENTION OF RECALL, NO SERVICE EVALUATION OF PARTICLE DEGRADATION HAS BEEN DETERMINED TO HAVE OCCURRED AND SHOULD BE FILED AS ADVERSE EVENT ONLY. HENCE, THIS SECTION: DESCRIBE EVENT OR PROBLEM (B5), ADVERSE EVENT/PRODUCT PROBLEM, TYPE OF REPORTED COMPLAINT, HEALTH IMPACT, REMEDIAL ACTION INIT(H7) AND RECALL (Z) NUMBER(H8) HAVE BEEN UPDATED.

    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 RECEIVED INFORMATION ALLEGING PATIENT HAS PASSED AWAY. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. CORRECTION TO PREVIOUS REPORT THAT THIS DEVICE WAS PART OF THE RECALL. AFTER EVALUATION, NO PARTICLE ALLEGATION, NO MENTION OF RECALL, NO SERVICE EVALUATION OF PARTICLE DEGRADATION HAS BEEN DETERMINED TO HAVE OCCURRED AND SHOULD BE FILED AS ADVERSE EVENT ONLY. HENCE, THIS SECTION: ADVERSE EVENT/PRODUCT PROBLEM, TYPE OF REPORTED COMPLAINT, HEALTH IMPACT, REMEDIAL ACTION INIT(H7) AND RECALL (Z) NUMBER(H8) HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    IN THIS REPORT, BOX B: ADVERSE EVENT OR PRODUCT PROBLEM (DESCRIBE EVENT OR PROBLEM) AS THE MANUFACTURER RECEIVED INFORMATION ALLEGING PATIENT HAS PASSED AWAY. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THIRD PARTY SERVICE CENTER AND EVALUATED. EVALUATION RESULT STATED THAT NO FOAM PARTICLES WERE OBSERVED. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED, BOX D: SUSPECT MEDICAL DEVICE (OPERATOR OF DEVICE), BOX G: ALL MANUFACTURERS (REPORT SOURCE), BOX H: DEVICE MANUFACTURERS (EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, CONCLUSION CODE GRID) HAVE BEEN CORRECTED/UPDATED.

    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 PATIENT HAS PASSED AWAY. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION IN RELATION TO A DREAMSTATION AUTO CPAP UNIT. THE DEVICE WAS REPORTED AS PART OF RECALL ACTIONS WITH NO INITIAL COMPLAINT ON THE DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING PATIENT HAS PASSED AWAY. THERE IS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. 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
    986539 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. RGBX500S15

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death