BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DS2ADV AUTO CPAP W/HUMID+HT CELL/BT

    MDR report key: 22893184 · Received August 26, 2025

    Report

    Report Number
    2518422-2025-109335
    Event Type
    Injury
    Date Received
    August 26, 2025
    Date of Event
    August 21, 2025
    Report Date
    May 27, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959075634
    PMA / PMN Number
    K200480
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION ALLEGING THAT THE HUMIDIFIER IS NOT WORKING AND IT IS CAUSING DRYING PATIENT'S THROAT. NO INFORMATION IF MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE PREVIOUS REPORT WAS SUBMITTED AS A SERIOUS INJURY. UPON REVIEW, IT WAS DETERMINED THAT THIS REPORT IS A PRODUCT PROBLEM. DHR REVIEW WAS PERFORMED FOR THE COMPLAINT DEVICE SERIAL NUMBER, D132864832DBF6. REVIEW CONFIRMS THAT THE DEVICE MET THE FINAL ACCEPTANCE CRITERIA AND WAS RELEASED FOR FINAL DISTRIBUTION. 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. MULTIPLE GOOD FAITH EFFORTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION, WITHOUT CUSTOMER RESPONSE. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ON A DREAMSTATION 2.0, ALLEGING THAT HIS HUMIDIFIER IS NOT WORKING AND IT'S DRYING HIS THROAT. NO INFORMATION IF MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A SUPPLEMENTAL FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319577 DS2ADV AUTO CPAP W/HUMID+HT CELL/BT VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520T11C 00606959075634

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male