BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO, FR

    MDR report key: 12727123 · Received November 1, 2021

    Report

    Report Number
    2518422-2021-05994
    Event Type
    Injury
    Date Received
    November 1, 2021
    Date of Event
    August 1, 2019
    Report Date
    November 1, 2021
    Manufacturer
    RESPIRONICS INC
    Product Code
    BZD
    UDI-DI
    00606959043060
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED A PATIENT TO DEVELOP LUNG ATROPHY AND AN UNSPECIFIED ORPHAN DISEASE. THERE IS NO REPORT OF THE MEDICAL INTERVENTION THAT THE PATIENT HAS RECEIVED AT THIS TIME. 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
    1630046 DREAMSTATION AUTO, FR VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC FRX500S14 00606959043060

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other