BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION ASV

    MDR report key: 12099213 · Received June 30, 2021

    Report

    Report Number
    MW5102216
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 26, 2021
    Manufacturer
    PHILIPS / RESPIRONICS INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    STARTING USING PHILIPS RESPIRONICS DREAMSTATION ASV IN (B)(6) 2021. IN (B)(6) 2021 HAVING SEVERE IRRITATION OF ESOPHAGUS, CHEST PRESSURE, DIZZINESS, NAUSEA AND HYPERSENSITIVITY AND IT'S ONGOING. WAS INFORMED YESTERDAY, (B)(6) 2021 OF THE MEDICAL DEVICE RECALL. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989613 DREAMSTATION ASV VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PHILIPS / RESPIRONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Disability