BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION

    MDR report key: 20905636 · Received December 11, 2024

    Report

    Report Number
    2518422-2024-105346
    Event Type
    Injury
    Date Received
    December 11, 2024
    Date of Event
    February 1, 2024
    Report Date
    May 16, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959424593
    PMA / PMN Number
    K131982
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PATIENT EXPERIENCED BI LATERAL PNEUMONIA AND HAD A ENDOSCOPY PERFORMED. THE PATIENT IS REQUESTING A REFUND ON THE DEVICE. THE DEVICE WAS RETURNED FOR EVALUATION TO THE MANUFACTURER. THE DEVICE HAD DUST-LIKE CONTAMINATION IN THE AIR INLET OF THE BLOWER BOX AND DIRT-LIKE CONTAMINATION IN THE HUMIDIFIER. THE DEVICE HAD BLACK DUST-LIKE CONTAMINATION ON THE TOP ENCLOSURE OF THE BASE AND BLACK DUST-LIKE CONTAMINATION ON THE UI PANEL. THERE WAS WHITE FOAM IN THE BLOWER BOX SHOWING THE DEVICE WAS A REMEDIATED DEVICE AND BLACK DUST-LIKE CONTAMINATION WAS FOUND ON THE REAR PANEL. THERE WERE POTENTIAL MINERAL SPOTS ON THE MOTOR SHOWING WATER INGRESS. THE DEVICE HAD BLACK CONTAMINATION CONSISTENT WITH KERATIN AT THE AIR OUTLET OF THE BLOWER BOX WHICH IS CONSISTENT WITH ER 2243857 V01. THE CUSTOMER'S COMPLAINT WAS NOT CONFIRMED, AND THE SPECIFIED SYMPTOMS COULD NOT BE ADDRESSED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE PATIENT EXPERIENCED BILATERAL PNEUMONIA AND HAD A ENDOSCOPY PERFORMED. THE PATIENT IS REQUESTING A REFUND ON THE DEVICE. 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
    2436771 DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. AUX500S15 00606959424593

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention