BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SLEEPWARE

    MDR report key: 22773479 · Received August 11, 2025

    Report

    Report Number
    2518422-2025-108959
    Event Type
    Malfunction
    Date Received
    August 11, 2025
    Date of Event
    February 7, 2025
    Report Date
    August 11, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    OLZ
    UDI-DI
    00606959045255
    PMA / PMN Number
    K142988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REGARDS TO A PATIENT STATING SHE FELT HEAT FROM THE UNIT AND IT MADE A RED BURN MARK ON HER CHEST. THE UNIT PERFORMED/RECORDED THE HSAT TEST AS NORMAL. 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
    2002671 SLEEPWARE AUTOMATIC EVENT DETECTION SOFTWARE FOR POLYSOMNOGRAPH WITH ELECTROENCEPHALOGRAPH OLZ RESPIRONICS, INC. 1082462 00606959045255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown