BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAL FLOWMETER

    MDR report key: 2854137 · Received November 9, 2012

    Report

    Report Number
    2854137
    Event Type
    Malfunction
    Date Received
    November 9, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 9, 2012
    Manufacturer
    PRECISION MEDICAL, INC
    Product Code
    CAN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US

    Narratives

    Description of Event or Problem · 1

    O2 FLOW METER WAS ASSEMBLED INCORRECTLY AT THE MANUFACTURING FACILITY. THE HIGH PRESSURE TAKE OFF LINE FOR A VENTILATOR HAD AN AIR FITTING INSTALLED WHERE THERE SHOULD BE AN O2 FITTING. MANUFACTURER CLAIMS ONLY THE 4 MISTAKENLY RECEIVED BY OUR FACILITY ARE AFFECTED. NO PATIENTS INVOLVED: EVENTS WERE DISCOVERED PRIOR TO THE DEVICE BEING USED ON A PATIENT. THIS EVENT WAS FOUND WHEN THE STAFF MEMBER NOTICED THE WRONG PART WAS ON THE ASSEMBLY. IT IS POSSIBLE THAT A USER NOT PAYING ATTENTION (HUMAN FACTOR) COULD MISTAKENLY HOOK UP AN AIR SUPPLY LINE TO AN O2 FLOW METER WHICH WOULD THEN PROVIDE AN INAPPROPRIATE AIR/O2 BLEND TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAL FLOWMETER FLOWMETER CAN PRECISION MEDICAL, INC 7MFA1005PTO 0812 AND (10291200058)

    Patients

    Seq Age Sex Outcome Treatment
    1 *