BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 12741306 · Received November 2, 2021

    Report

    Report Number
    2518422-2021-06159
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    July 1, 2021
    Report Date
    August 4, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 2518422-2022-04366 IS THE ORIGINAL REPORT ASSOCIATED WITH THIS DEVICE. A DUPLICATE REPORT HAS BEEN SUBMITTED FOR THIS DEVICE UNDER REPORT MDR 2518422-2021-06159. THIS FOLLOW-UP REPORT IS BEING FILED FOR AWARENESS OF THIS DUPLICATE REPORT. A CORRECTION REPORT MDR 2518422-2021-06159-1 HAS BEEN FILED FOR AWARENESS ABOUT THE DUPLICATE REPORT.

    Description of Event or Problem · 1

    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
    1636673 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female