BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DS2ADV AUTO CPAP

    MDR report key: 18741934 · Received February 20, 2024

    Report

    Report Number
    2518422-2024-08589
    Event Type
    Injury
    Date Received
    February 20, 2024
    Date of Event
    January 22, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K200480
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A DREAMSTATION 2 ADVANCED AUTO CPAP DEVICE IS GIVING THE PATIENT HIGH BLOOD PRESSURE. THE PATIENT STATED THAT HIS BLOOD PRESSURE WENT UP TO 156-160 AND HE NORMALLY HAS 120-126 BLOOD PRESSURE. THE PATIENT STATED HE WAS TOLD BY HIS DOCTOR THAT IS WAS BECAUSE OF THE DEVICE WHICH IS NOT SET WITH THE CORRECT PRESSURE SETTING. THE PATIENT WAS REFERRED TO PHILIPS TO GET A DEVICE WITH THE CORRECT SETTING. THE PATIENT REPORTS CLEANING ONLY THE ACCESSORIES WITH WATER AND SOAP PER THE INSTRUCTIONS. THE PRESSURE SETTING IS 5. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    1086641 DS2ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX520H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening