BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAR

    MDR report key: 12089750 · Received June 29, 2021

    Report

    Report Number
    2936999-2021-00632
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    April 2, 2021
    Report Date
    June 29, 2021
    Product Code
    BZA
    PMA / PMN Number
    K942392
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING USE, THE CONNECTOR DISCONNECTED THREE TIMES FROM THE PATIENT'S INTUBATION TUBE, WHICH CAUSED DESATURATIONS IN A SEDATED RESUSCITATED PATIENT. PATIENT HAS COVID19 HYPOXEMIC PNEUMONIA AND STILL IN INTENSIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985772 DAR CONNECTOR, AIRWAY (EXTENSION) BZA 332/5663 21A0225FAX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention