BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION CPAP

    MDR report key: 13174247 · Received January 6, 2022

    Report

    Report Number
    2518422-2022-00234
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    December 9, 2021
    Report Date
    July 25, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MDR 2518422-2022-00047 IS THE ORIGINAL REPORT ASSOCIATED WITH THIS DEVICE. A DUPLICATE REPORT HAS BEEN SUBMITTED FOR THIS DEVICE IN ERROR UNDER REPORT MDR 2518422-2022-00234. THIS FOLLOW-UP REPORT IS BEING FILED FOR AWARENESS OF THIS DUPLICATE REPORT. A CORRECTION REPORT MDR 2518422-2022-00234-1 HAS BEEN FILED FOR AWARENESS ABOUT THE DUPLICATE REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2022-00047. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP BACTERIAL PNEUMONIA. THE PATIENT WAS HOSPITALIZED IN RESPONSE TO THE REPORTED EVENT. 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
    57217 DREAMSTATION CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX200H11

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization