BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX MANOMETER

    MDR report key: 10179804 · Received June 22, 2020

    Report

    Report Number
    3012307300-2020-06124
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Report Date
    June 22, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    KRK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    117

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX MANOMETER WAS REPORTED TO BE KINKING OFF AND GIVING THE WRONG PRESSURE READING. THERE WERE NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643478 PORTEX MANOMETER MANOMETER, BLOOD-PRESSURE, VENOUS KRK SMITHS MEDICAL INTERNATIONAL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1