BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION 2 ADV AUTO CPAP

    MDR report key: 15675225 · Received October 26, 2022

    Report

    Report Number
    2518422-2022-86725
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    September 30, 2022
    Report Date
    January 4, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K200480
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY RECEIVED INFORMATION ALLEGING A DREAMSTATION 2 ADVANCED AUTO CPAP CONTRIBUTED TO DRY SINUSES, HEADACHES, SORE THROAT, AND POST-NASAL DRIP DUE TO INEFFECTIVE HUMIDIFICATION. THE USER REPORTEDLY WAS PRESCRIBED STEROIDS. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. DURING EVALUATION OF THE DEVICE, THE TECHNICIAN WAS ABLE TO CONFIRM THE DEVICE POWERS ON, PROVIDES AIRFLOW, A KNOWN GOOD, HEATED TUBE HEATS, AND THE HEATER PLATE HEATS. DURING REVIEW OF THE ERROR LOGS, IT WAS DETERMINED THAT THE DEVICE WAS LIKELY RESET PRIOR TO THE PRODUCT INVESTIGATION LAB RECEIPT DUE TO IT HAVING 1914.5 MACHINE HOURS AND 0 BLOWER AND THERAPY HOURS. THERE WERE 4 INCIDENTS OF E-250 (ERR_BAROMETRIC_COMM), A CONTINUE ERROR, AND 1 INSTANCE OF E-15 (ERR_CYCLE_HANDLER_OVERRUN), A REBOOT ERROR. THESE ERRORS WERE NOT REPRODUCED WITH CONTINUED USAGE. THE TECHNICIAN RAN THE DEVICE FOR A 2-HOUR PERIOD AND VERIFIED THAT THE TEMPERATURE OF THE HEATER PLATE WAS WITHIN THE NORMAL OPERATION RANGE PER 1143533 (V02) USING A FLUKE MULTIMETER (ID: F3890, S/N: (B)(6), CALDUE: (B)(6) 2024). DURING THE INVESTIGATION, THE TECHNICIAN OBSERVED AN UNKNOWN CONTAMINANT ON THE WATER TANK LID, WATER TANK, AND WATER TANK LID SEAL. AN UNKNOWN DUST CONTAMINANT WAS OBSERVED ON THE UI PANEL AND TOP ENCLOSURE. A HAIR-LIKE PARTICLE WAS OBSERVED ON THE CENTER ENCLOSURE. AN UNKNOWN DUST CONTAMINANT WAS OBSERVED ON THE INLET/OUTLET SEAL, ON THE INLET OF THE BLOWER BOX, ON THE BLOWER, AND THE BLOWER BOX. A HAIR-LIKE PARTICLE WAS OBSERVED ON THE BOTTOM ENCLOSURE. AN UNKNOWN DUST CONTAMINANT WAS OBSERVED ON THE HEATER PLATE AND BOTTOM ENCLOSURE. THE PRODUCT INVESTIGATION LAB IS UNABLE TO DIRECTLY ADDRESS THE SYMPTOMS OR THE COMPLAINT. THE MANUFACTURER HAS UPDATED SECTION H6 IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A DREAMSTATION 2 ADVANCED AUTO CPAP CONTRIBUTED TO DRY SINUSES, HEADACHES, SORE THROAT, AND POST-NASAL DRIP DUE TO INEFFECTIVE HUMIDIFICATION. THE USER REPORTEDLY WAS PRESCRIBED STEROIDS. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY. THE INVESTIGATION IS ON-GOING. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2761593 DREAMSTATION 2 ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Other