BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO BIPAP

    MDR report key: 12884173 · Received November 29, 2021

    Report

    Report Number
    2518422-2021-07329
    Event Type
    Injury
    Date Received
    November 29, 2021
    Date of Event
    November 10, 2021
    Report Date
    November 29, 2021
    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

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A BIPAP DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED BREATHING/HEART ISSUES AND WAS DIAGNOSED WITH CANCER. THE PATIENT DID REPORT RECEIVING MEDICAL INTERVENTION AND SAW A PHYSICIAN FOR HER DIAGNOSIS. 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
    1780206 DREAMSTATION AUTO BIPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX700T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other