BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURITY

    MDR report key: 9520163 · Received December 26, 2019

    Report

    Report Number
    8040459-2019-00126
    Event Type
    Injury
    Date Received
    December 26, 2019
    Date of Event
    November 22, 2019
    Report Date
    December 26, 2019
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US WITH 510(K) NUMBER K892432. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT WAS INTUBATED IMMEDIATELY DUE TO SHORTNESS OF BREATH AND DECREASED OF BLOOD OXYGEN. DURING USE, IT WAS FOUND THAT THE AIR BAG COULD NOT BE INFLATED. THE DEVICE WAS PULLED OUT AND FOUND OUT THAT THE AIR BAG WAS BROKEN. THE PATIENT WAS REINTUBATED USING A NEW DEVICE AND USED IT NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315342 CURITY TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9475E 1835452FED

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention