BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATA COMM II LAB MANAGEMENT SYSTEM

    MDR report key: 57790 · Received December 24, 1996

    Report

    Report Number
    MW1010454
    Event Type
    Malfunction
    Date Received
    December 24, 1996
    Manufacturer
    AVL SCIENTIFIC CORP.
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    AN ARTERIAL BLOOD GAS WAS RUN AT 0035 10/24/96, BUT BLOOD GAS DATA MANAGEMENT SYSTEM PRINTED THE PRIOR RESULT ON THAT SPECIFIC PT, WHICH HAD BEEN ACTUALLY RUN ON 10/23/96 AT 2325. MFR FOLLOWED UP BY DOING A COMPLETE UPGRADE ON COMPUTER SYSTEM, NO FURTHER OCCURRENCES, CONTINUES TO MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATA COMM II LAB MANAGEMENT SYSTEM ARTERIAL BLOOD GAS ANALYZER CHL AVL SCIENTIFIC CORP. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other