BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REP DREAMSTATION AUTO BIPAP

    MDR report key: 20056362 · Received August 23, 2024

    Report

    Report Number
    2518422-2024-53357
    Event Type
    Injury
    Date Received
    August 23, 2024
    Date of Event
    October 9, 2023
    Report Date
    August 12, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959025691
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION HAS BEEN COMPLETED, THE FOLLOWING FIELDS HAS BEEN 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, AND CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER 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 MANUFACTURER SERVICE CENTER. THERE WAS ONE ERROR CODE FOUND. THE MANUFACTURER SERVICE CENTER CONCLUDES THAT THEY COULDN'T CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED. IN BOX D: PRODUCT BRAND NAME, MODEL NUMBER AND CATALOG NUMBER HAS BEEN UPDATED. IN BOX H: EVALUATION METHOD CODE, EVALUATION RESULTS CODE, CONCLUSION CODE GRID HAS BEEN UPDATED.

    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 DIZZINESS, HEADACHE, AND CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246250 REP DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX700S11F 00606959025691

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other