BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION 2 ADV AUTO CPAP

    MDR report key: 21504474 · Received March 3, 2025

    Report

    Report Number
    2518422-2025-102537
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 6, 2025
    Report Date
    May 28, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959062566
    PMA / PMN Number
    K200480
    Removal / Correction Number
    Z-1972-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SENT TO CORRECT OUR PREVIOUS SUBMISSION. UPDATED THE FOLLOWING: 510K: K200480. UDI: (B)(4). BOX D: DEVICE AVAILABLE FOR EVALUATION: YES. DATE RETURNED (RFB): 6/3/2025. BOX G: DATE RETURNED (RFB): FOREIGN. BOX H: DEVICE EVAL. BY MFG? NO INFORMATION. MANUFACTURE DATE: 7/22/2022. DEVICE AVAILABLE FOR EVALUATION? YES. REMEDIAL ACTION INIT (RFB): NA. RECALL (Z) NUMBER (RFB): NA.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION RELATED TO A DREAMSTATION 2 ADV AUTO CPAP DEVICE. THE PATIENT ALLEGES THE DEVICE IS OVERHEATING AND MELTING INTO THE LAMINATE TABLE. THERE WAS NO SERIOUS PATIENT HARM OR INJURY. THERE WAS NO MEDICAL INTERVENTION REPORTED. 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
    469061 DREAMSTATION 2 ADV AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. CAX521H12C 00606959062566

    Patients

    Seq Age Sex Outcome Treatment
    1