BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR CASSETTE

    MDR report key: 4024968 · Received August 13, 2014

    Report

    Report Number
    MW5037780
    Event Type
    Injury
    Date Received
    August 13, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 12, 2014
    Manufacturer
    RADIOMETER AMERICA
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    A NEW SENSOR CASSETTE WAS PLACED ON THE RADIOMETER ABL 80-COOX BLOOD GAS INSTRUMENT (B)(6) 2014 AT APPROXIMATELY 1500 BECAUSE ALL THE TEST HAD BEEN USED. PART #945-714 LOT #205624, INSTRUMENT SERIAL #(B)(4) . ONCE CHANGED AND INSTALLED, THE INSTRUMENT PERFORMS A SYSTEM CYCLE (INTERNAL QUALITY CONTROL CHECK) ANDA 2PT CALIBRATION. THE SYSTEM CYCLE DID NOT PERFORM THE SYSTEM CYCLE BUT PERFORMED THE 2PT CALIBRATION. SYSTEM CYCLES ARE SUPPOSE TO PERFORM EVERY 8 HOURS DAILY. THE 2PT CALIBRATION PERFORMS AFTER A SENSOR CASSETTE HAS BEEN CHANGED THEN AND 30 MINUTES AFTERWARDS. IN THIS CASE, THE SYSTEM CYCLE FAILED TO PERFORM BUT THE 2 PT CALIBRATION PERFORMED EVERY 8 HOURS INSTEAD. EACH DAY, THE 2PT CALIBRATION PERFORMED CHECKS EVERY 8 HOURS FROM (B)(4) 2014 AT 1600 UNTIL TECH SUPPORT WAS CALLED ON (B)(4) 2014 AT APPROXIMATELY 1530.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483399 SENSOR CASSETTE CGA RADIOMETER AMERICA 945-714 205624

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention