BEUDAMED
    FDA Adverse Event Death Summary report: N

    REP DREAMSTATION AUTO CPAP

    MDR report key: 19834813 · Received July 26, 2024

    Report

    Report Number
    2518422-2024-47292
    Event Type
    Death
    Date Received
    July 26, 2024
    Date of Event
    October 9, 2023
    Report Date
    August 12, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959025639
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    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 PATIENT IS ALLEGING EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE, QUINTUPLE BYPASS HEART SURGERY, THREE SEPARATE STROKES, MASS FOUND IN THE BRAIN. IN ADDITION, THE PATIENT ALSO HYPERSENSITIVITY, INFLAMMATORY RESPONSE, CANCER AND DEATH. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED. 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. DURING THE EVALUATION, THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. 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 THIS REPORT, IN BOX E REPORTING INSTITUTION NAME HAS BEEN UPDATED/CORRECTED. IN BOX H REMEDIAL ACTION INIT, RECALL (Z) NUMBER, PROBLEM CODE, METHOD CODE, RESULTS CODE AND CONCLUSION CODE HAS BEEN UPDATED/CORRECTED.

    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 PATIENT IS ALLEGING EYE IRRITATION, NOSE IRRITATION, SKIN IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE, QUINTUPLE BYPASS HEART SURGERY, THREE SEPARATE STROKES, MASS FOUND IN THE BRAIN. IN ADDITION, THE PATIENT ALSO HYPERSENSITIVITY INFLAMMATORY RESPONSE CANCER DEATH. AT THIS TIME, NO MEDICAL INTERVENTION HAS BEEN REPORTED. 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
    484906 REP DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX500S11F 00606959025639

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death