BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAPILLIARY TUBES FOR ABL5 BLOODGAS ANALYZER

    MDR report key: 692773 · Received March 22, 2006

    Report

    Report Number
    3002807968-2006-00020
    Event Type
    Other
    Date Received
    March 22, 2006
    Date of Event
    February 17, 2006
    Report Date
    March 22, 2006
    Manufacturer
    *
    Product Code
    GIO
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAS OBSERVED SMALL BOBBLES OF AIR IN THE MEASURING CHAMBER OF THEIR ABL5, BLOODGAS ANALYZER AND SOMETIMES THE MEASUREMENT OF THE P02 VALUE IS TO HIGH, IN RELATION TO WHAT WAS EXPECTED. THE CUSTOMER USED A WROONG SIZE OF CAPILLARY TUBES. THE ANALYZER REQUIRES A MINIMUM OF 85 UL TO PERFORM A CORRECT MEASUREMENT OF ALL PARAMETERS. IF THE USER ONLY PROVIDES 55 UL THE ANALYZER WILL NOT GET ENOUGH BLOOD TO ENSURE CORRECT MEASUREMENTS. THIS CAUSES THAT THE P02 VALUE WILL BE TO HIGH AND SOMETIMES CLOSE TO THE VALUE OF ATMOSPHERIC AIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPILLIARY TUBES FOR ABL5 BLOODGAS ANALYZER CAPILLARY TUBES GIO * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other