BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 20830711 · Received December 3, 2024

    Report

    Report Number
    2518422-2024-072756
    Event Type
    Injury
    Date Received
    December 3, 2024
    Date of Event
    October 9, 2023
    Report Date
    October 15, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959424197
    PMA / PMN Number
    K131982
    Removal / Correction Number
    K131982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN PREVIOUS REPORT THE MANUFACTURER MISSED TO CODE C171286 AND C26871 PATIENT OUTCOME CODES IN THIS REPORT IT WAS CAPTURED. SECTION H6 WAS UPDATED.

    Additional Manufacturer Narrative · 0

    REPAIR EVALUATION INFORMATION WAS RECEIVED ON 04/23/2024 AND SECTION H11 SHOULD BE REPORTED AS: 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 EYE IRRITATION DIZZINESS, HEADACHE; KIDNEY DISEASE/TOXICITY, LIVER DISEASE/TOXICITY, LUNG DISEASE AND COPD. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTRE FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTRE, THE DEVICE WAS VISUALLY INSPECTED AND FOUND NO PARTICLES IN AIR PATH. DURING THE EVALUATION, SECONDARY FINDINGS WAS OBSERVED. THERE WAS ZERO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTRE CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION. BOX H WAS UPDATED IN THIS REPORT.

    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 MANUFACTURER RECEIVED INFORMATION ALLEGING EYE IRRITATION DIZZINESS, HEADACHE; KIDNEY DISEASE/TOXICITY, LIVER DISEASE/TOXICITY, LUNG DISEASE AND COPD. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2290247 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11 00606959424197

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other