BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REP DREAMSTATION AUTO

    MDR report key: 17117223 · Received June 13, 2023

    Report

    Report Number
    2518422-2023-13382
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    December 9, 2022
    Report Date
    May 14, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGATION OF THEY WAKE UP FEELING DRY, HAS BLOODY NOSES, SINUS INFECTION, HAS BEEN PRESCRIBED ANTIBIOTICS AND NASAL SPRAY. PATIENT STATES USE VINEGAR AND WATER TO CLEAN THE DEVICE. NO OTHER PERIPHERALS OR ACCESSORIES WERE RETURNED WITH THE DEVICE. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURE INSPECTED EXTERNALLY OBSERVED THAT USING A WELL-KNOWN PIL SUPPLIED POWER SUPPLY AND AC POWER CORD. PIL ALSO OBSERVED CUSTOMERS HUMIDIFIER HEATER PLATE DID HEAT. PIL USED A WELL-KNOWN PIL SUPPLIED HEATED TUBE ON CUSTOMER SUPPLIED HUMIDIFIER. PIL OBSERVED THE PIL SUPPLIED KNOWN GOOD, HEATED TUBE DID OPERATE. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) PIL TECH WAS ABLE TO CONFIRM THE DEVICE POWERS ON, PROVIDES AIRFLOW, A KNOWN GOOD, HEATED TUBE HEATS, AND THE HEATER PLATE HEATS AND THERE WERE NO ERRORS LOGGED THE MANUFACTURER CONCLUDES THAT UNKNOWN DUST CONTAMINANT WAS OBSERVED ON THE TOP ENCLOSURE, UI PANEL, BOTTOM ENCLOSURE, BLOWER, AND BLOWER BOX. PIL CAN CONFIRM DEBRIS IN THE AIRPATH, LIKELY DUE TO AN OUTSIDE ENVIRONMENTAL SOURCE. A DARK BACTERIA SUBSTANCE WAS OBSERVED ON THE WATER TANK AND TANK SEAL. AN UNKNOWN DUST CONTAMINANT WAS OBSERVED ON THE HUMIDIFIER ENCLOSURE. A DARK CONTAMINANT WAS OBSERVED ON THE DRY BOX. AN INSECT WAS OBSERVED ON THE HEATER PLATE. THIS IS A REMEDIATED DEVICE AND DOES NOT FALL UNDER THE SCOPE OF UNO, THERE IS NO INVESTIGATION INTO FOAM DEGRADATION. BOX H: DEVICE PROBLEM CODE GRID, EVALUATION METHOD CODE, EVALUATION RESULTS CODE AND CONCLUSION CODE GRID HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING DISSATISFACTION AND HARM WHILE ON THE REPLACEMENT DREAM STATION AUTO CPAP DEVICE. THE PATIENT ALLEGES SHE DOES NOT LIKE THE DEVICE. THE PATIENT ALSO ALLEGES SHE USED THE DEVICE FOR A COUPLE DAYS AND HAS BEEN TERRIBLY DRY UPON WAKING UP WHICH LED TO SINUS INFECTIONS AND A BLOODY NOSE. THE PATIENT STATED SHE WENT TO THE DOCTOR IN WHICH THEY PRESCRIBED HER A ANTIBIOTIC AND NASAL SPRAY. THE DEVICE WAS RETURNED TO THE MANUFACTURER. INVESTIGATION IS ANTICIPATED BUT NOT YET BEGUN. . IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1986667 REP DREAMSTATION AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX500S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other