BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMVEX (OHIO MEDICAL) FMA 4906 FLOWMETER

    MDR report key: 11332263 · Received February 12, 2021

    Report

    Report Number
    MW5099385
    Event Type
    Injury
    Date Received
    February 12, 2021
    Date of Event
    February 2, 2021
    Report Date
    February 10, 2021
    Product Code
    CAX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ENDOSCOPIC PROCEDURE, THE CO2 FLOWMETER WAS CONNECTED DIRECTLY TO THE GAS CANNISTER THROUGH A HOSE WITHOUT A REGULATOR INLINE BETWEEN THE CANNISTER AND THE FLOWMETER. THE FLOWMETER IMMEDIATELY BURST UNDER THE PRESSURE WHEN THE CANNISTER FLOW WAS INITIATED. THERE WAS NO INJURY TO THE PATIENT. THIS WAS DETERMINED TO BE AN ERROR IN COMPONENT SETUP BY STAFF. IMAGING WAS PERFORMED TO ENSURE THAT NO SHARDS OF GLASS WERE ON OR IN THE PATIENT, BUT THE PATIENT WAS COVERED AT THE TIME OF THE FLOWMETER BURSTING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216756 AMVEX (OHIO MEDICAL) FMA 4906 FLOWMETER FLOWMETER, TUBE, THORPE, BACK-PRESSURE COMPENSATED CAX FMA 4906

    Patients

    Seq Age Sex Outcome Treatment
    1