BEUDAMED
    FDA Adverse Event Other Summary report: N

    FLOW METER

    MDR report key: 2897543 · Received December 3, 2012

    Report

    Report Number
    2523148-2012-00006
    Event Type
    Other
    Date Received
    December 3, 2012
    Manufacturer
    PRECISION MEDICAL, INC.
    Product Code
    CAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN CONCLUSION THIS ERROR APPEARS NOT TO BE A FAULT OF THE DEVICE, BUT OF THE CARE GIVER. THE IMMEDIATE SOLUTION WOULD BE TRAINING AND VIGILANCE, WITH LONG TERM, A STANDARD CORRECTION, TO THE AIR FLOW METERS AND CANNULAS, FORCED ACROSS THE INDUSTRY BY THE FDA AND THE (B)(4).

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW METER CAX PRECISION MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR