BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 15328200 · Received August 31, 2022

    Report

    Report Number
    2518422-2022-77191
    Event Type
    Injury
    Date Received
    August 31, 2022
    Date of Event
    November 3, 2021
    Report Date
    August 31, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED VOLUNTARY MEDWATCH (MW5105529) ALLEGING AN ISSUE RELATED TO A BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP) DEVICE. THE MANUFACTURER RECEIVED INFORMATION ALLEGING COUGH WHILE USING THIS DEVICE AND MEDICAL INTERVENTION WAS PRESCRIPTION MEDICATIONS. DESPITE OF MULTIPLE ATTEMPTS THE DEVICE HAS NOT YET RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2469051 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other