BEUDAMED
    FDA Adverse Event Death Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 23621513 · Received November 21, 2025

    Report

    Report Number
    2518422-2025-054977
    Event Type
    Death
    Date Received
    November 21, 2025
    Date of Event
    December 14, 2023
    Report Date
    May 19, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959062733
    PMA / PMN Number
    K200480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS REPORT DEVICE IS EVALUATED ON 5/12/2026. PARTICLES AND ANY TYPE OF CONTAMINATION ARE NOT FOUND IN DEVICE. IN H SECTION CODES ARE ADDED/ UPDATED. RISK ASSESSMENT COMMENT IS ADDED. THE REPORTED FAILURE OF THERMAL ISSUE IS ACCOMMODATED IN THE PRODUCT RISK MANAGEMENT FILE AS BEING LINKED TO HAZARD WITH DESCRIPTION FIRE, FLAME, SMOKE. COMPLAINTS FOR THIS FAILURE ARE REVIEWED VIA THE POST MARKET COMPLAINT TRENDING AND ESCALATION PROCESSES TO ASSESS FOR THE OBSERVED PROBABILITY LEVELS AND COMPARE THEM WITH THE PREDICTED LEVELS IN THE RISK FILE FOR THE HAZARDS LINKED TO THE FAILURE. AS OF THE DATE OF SUBMISSION FOR THIS REPORT, THERE IS NO FURTHER INDICATION THAT COMPLAINTS FOR THE FAILURE IN QUESTION HAS LED TO UNACCEPTABLE INCREASE IN PROBABILITY LEVELS FOR THE HAZARDOUS SITUATIONS IN SCOPE, AND THEREFORE NO FURTHER ACTION WILL BE PURSUED. QA CONTINUES TO MONITOR COMPLAINTS FOR THIS ISSUE PER THE CADENCE IN THE COMPLAINT TRENDING PROCEDURES.

    Additional Manufacturer Narrative · 0

    THIS NOTIFICATION WAS RE-EVALUATED FOLLOWING RECEIPT AND REVIEW OF ALL AVAILABLE INFORMATION RELATED TO THE REPORTED PATIENT DEATH. AT THE TIME OF INITIAL REPORTING, THE EVENT WAS CONSERVATIVELY SUBMITTED DUE TO THE LIMITED INFORMATION AVAILABLE. HOWEVER, SUBSEQUENT REVIEW CONFIRMS THAT THERE IS NO ALLEGATION OR EVIDENCE SUGGESTING THAT THE DEVICE MALFUNCTIONED, FAILED, OR OTHERWISE CONTRIBUTED TO THE REPORTED OUTCOME. THEREFORE, THIS CASE HAS BEEN REASSESSED AND DETERMINED TO BE NON-REPORTABLE. THE EVENT WILL CONTINUE TO BE DOCUMENTED AND TRENDED PER INTERNAL QUALITY SYSTEM REQUIREMENTS.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE OF A USER OF A DS2ADV AUTO CPAP ALLEGING PATIENT WAS DEATH WHILE USING THE DEVICE. THERE WAS REPORT OF PATIENT DEATH. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617525 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIR ATOR) BZD RESPIRONICS, INC. DSX520H11C 00606959062733

    Patients

    Seq Age Sex Outcome Treatment
    1