BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO

    MDR report key: 13004992 · Received December 14, 2021

    Report

    Report Number
    2518422-2021-08129
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    December 3, 2021
    Report Date
    December 14, 2021
    Manufacturer
    PHILIPS RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1897807 DREAMSTATION AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS RESPIRONICS, INC. ESX500H15

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown