BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO

    MDR report key: 14634671 · Received June 8, 2022

    Report

    Report Number
    2518422-2022-34721
    Event Type
    Injury
    Date Received
    June 8, 2022
    Date of Event
    June 6, 2022
    Report Date
    October 4, 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
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2022-103500. 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 CPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED CHEST TIGHTNESS, IRRITATING COUGH, SHORTNESS OF BREATH, HEADACHE, IRRITATED EYES, EARACHE, COLD, TRACHEA DISCOMFORT, GASTROINTESTINAL ISSUES, FATIGUE AND LUNG NODULES. THE PATIENT DID REPORT TO RECEIVE MEDICAL INTERVENTION AND HAD A CT SCAN ON (B)(6) 2020. 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
    2217954 DREAMSTATION AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. FRX500S14

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O