BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TUBE, TRACHEAL (W/WO CONNECTOR)

    MDR report key: 7229370 · Received January 30, 2018

    Report

    Report Number
    8040459-2018-00011
    Event Type
    Injury
    Date Received
    January 30, 2018
    Date of Event
    January 11, 2018
    Report Date
    January 30, 2018
    Manufacturer
    KENDALL GAMMATRON, THAILAND
    Product Code
    BTR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    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, DURING NORMAL USE, THE UNIT HAD CUFF BREAKAGE. THE CUSTOMER INDICATED THAT A CUFF LEAK OCCURRED AND THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71417 TUBE, TRACHEAL (W/WO CONNECTOR) BTR KENDALL GAMMATRON, THAILAND 9570E 1702356FED

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention