BEUDAMED
    FDA Adverse Event Death Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 21954549 · Received May 2, 2025

    Report

    Report Number
    2518422-2025-105132
    Event Type
    Death
    Date Received
    May 2, 2025
    Date of Event
    May 1, 2025
    Report Date
    April 17, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959410848
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT WITH A DREAMSTATION AUTO CPAP DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE CAUSE OF DEATH WAS NOT PROVIDED. NO ADDITIONAL DETAILS WERE PROVIDED. THIS NOTIFICATION WAS EVALUATED FOLLOWING RECEIPT AND REVIEW OF ALL AVAILABLE INFORMATION RELATED TO THE REPORTED PATIENT DEATH. REVIEW CONFIRMS THAT THERE IS NO ALLEGATION OR EVIDENCE SUGGESTING THAT THE DEVICE MALFUNCTIONED, FAILED, OR OTHERWISE CONTRIBUTED TO THE REPORTED OUTCOME. SPECIFICALLY: NO DEVICE DEFICIENCY (E.G., MALFUNCTION, MISUSE, LABELING ISSUE, OR PERFORMANCE FAILURE) HAS BEEN IDENTIFIED. NO CAUSAL OR CONTRIBUTORY RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED DEATH HAS BEEN ESTABLISHED. THE AVAILABLE INFORMATION INDICATES THE DEATH IS ATTRIBUTABLE TO FACTORS UNRELATED TO THE DEVICE. BASED ON THE TOTALITY OF EVIDENCE, THIS EVENT DOES NOT MEET THE CRITERIA FOR REPORTABILITY, AS THERE IS NO REASONABLE POSSIBILITY THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH; THEREFORE, THIS CASE HAS BEEN ASSESSED AND DETERMINED TO BE NON-REPORTABLE. THE EVENT WILL CONTINUE TO BE DOCUMENTED AND TRENDED PER INTERNAL QUALITY SYSTEM REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT WITH A DREAMSTATION AUTO CPAP DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE CAUSE OF DEATH WAS NOT PROVIDED. NO ADDITIONAL DETAILS WERE PROVIDED. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THREE ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION VIA EMAIL TO THE NHS (NATIONAL HEALTH SERVICE) ([email protected]) ON 06/30/2025, 07/03/2025, 07/09/2025. NO RESPONSE WAS RECEIVED. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT WITH A DREAMSTATION AUTO CPAP DEVICE HAS PASSED AWAY. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. THE CAUSE OF DEATH WAS NOT PROVIDED. NO ADDITIONAL DETAILS WERE PROVIDED. 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
    1072473 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. RGBX500S15 00606959410848

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death