BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IL 482 CO-OXIMETER

    MDR report key: 359165 · Received October 27, 2001

    Report

    Report Number
    1217183-2001-00003
    Event Type
    Malfunction
    Date Received
    October 27, 2001
    Report Date
    October 26, 2001
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Product Code
    JKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCORDING TO THE COMPLAINT TEXT, AN INCIDENT OCCURRED WITH A CUSTOMER'S IL 482 CO-OXIMETER IN THEIR NEONATAL INTENSIVE CARE UNIT. CALIBRATION WAS SUCCESSFULLY PERFORMED ON THE INSTRUMENT, AS WERE THREE ACCEPTABLE LEVELS OF CONTROLS; HOWEVER, THE METHEMOGLOBIN RESULTS WERE QUESTIONABLE (MET HGB RESULT BETWEEN 5-10 FOR NEONATES RECEIVING NITRIC OXIDE THERAPY). THE PROBLEM WAS LATER DETERMINED BY SERVICE TO BE DUE TO THE HEMOLYZER. THE PART WAS REPLACED AND RESULTS WERE CHECKED AND CORRELATED TO AN ALTERNATE SITE. BASED ON THESE ELEVATED METHEMOGLOBIN VALUES, PATIENT'S (NEONATES) WERE TREATED MORE AGGRESSIVELY BEFORE THE PROBLEM WAS DISCOVERED. THERE IS NO INDICATION FROM THE COMPLAINT OR A FOLLOW-UP LETTER FROM THE SITE THAT THE NEONATES INVOLVED WERE ADVERSELY IMPACTED BY THE MORE AGGRESSIVE TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48277 IL 482 CO-OXIMETER CO-OXIMETER JKS INSTRUMENTATION LABORATORY CO. 482 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN