BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 19937820 · Received August 8, 2024

    Report

    Report Number
    2518422-2024-49804
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    October 9, 2023
    Report Date
    August 20, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959051515
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION IN REFERENCE TO A DREAMSTATION AUTO CPAP DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING DIZZINESS, HEADACHE, INFLAMMATORY RESPONSE, KIDNEY DISEASE/TOXICITY, AND RESPIRATORY ISSUES (DIFFICULTY BREATHING). MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. UPDATED: 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 DIZZINESS, HEADACHE, INFLAMMATORY RESPONSE, KIDNEY DISEASE/TOXICITY, AND RESPIRATORY ISSUES (DIFFICULTY BREATHING). MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. SECTION B: ADVERSE EVENT/PRODUCT PROBLEM: "UPDATED TO BOTH." SECTION D: MODEL NUMBER UPDATED. CATALOG ITEM IDENTIFIER UPDATED. PRODUCT UDI UPDATED. SECTION H: DEVICE PROBLEM CODE GRID UPDATED. REMEDIAL ACTION INITIATED FIELDS UPDATED. RECALL NUMBER FIELDS 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 DIZZINESS, HEADACHE, INFLAMMATORY RESPONSE, KIDNEY DISEASE/TOXICITY, AND RESPIRATORY ISSUES (DIFFICULTY BREATHING). MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, SECONDARY FINDINGS WAS OBSERVED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTRE. THERE WAS ONE ERROR CODE FOUND. 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. BOX H: EVALUATION METHOD CODE, EVALUATION RESULTS CODE, CONCLUSION CODE GRID HAS BEEN UPDATED. IN PREVIOUS REPORT RECALL (Z) NUMBER CAPTURED WRONGLY, IN THIS REPORT HAS BEEN UPDATED CORRECTLY.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO A DREAMSTATION AUTO CPAP DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING DIZZINESS, HEADACHE, INFLAMMATORY RESPONSE, KIDNEY DISEASE/TOXICITY, AND RESPIRATORY ISSUES (DIFFICULTY BREATHING). MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    2396181 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C 00606959051515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other