BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO

    MDR report key: 17883134 · Received October 5, 2023

    Report

    Report Number
    2518422-2023-25712
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 5, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT YET RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A THERMAL EVENT ON A DREAMSTATION AUTO CPAP DEVICE. THE DEVICE AND SD CARD WAS BROUGHT " TO A HOSPITAL AND IT WAS ANALYZED AS USUAL. THE PATIENT SAW A DOCTOR. WHEN THE PATIENT STARTED TO USE THE DEVICE, THE DEVICE MAIN BODY GREW HOT AND 'SERVICE REQUIRED 041322-01520' WAS DISPLAYED. A PART OF THE SD CARD MELTED. A REPLACEMENT WAS DONE." THERE WAS NO HARM OR INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED REGARDING SPECIFICS OF WHO REPORTED THE ISSUE, OR IF THERE HAS BEEN ANY DEVICE EVALUATION FINDINGS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. 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
    1072380 DREAMSTATION AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. JPX500S16

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown