BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSICATH

    MDR report key: 196413 · Received November 6, 1998

    Report

    Report Number
    2183943-1998-00001
    Event Type
    Malfunction
    Date Received
    November 6, 1998
    Report Date
    November 2, 1998
    Manufacturer
    OPTICAL SENSORS, INC.
    Product Code
    CCE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT REFERS TO A PRODUCT PROBLEM OR MALFUNCTION WHICH RESULTED FROM USER ERROR INVOLVING THE IMPROPER USE OF A TRAINING DEVICE. DURING A SITE VISIT, THE CLINICAL SUPPORT SPECIALIST, OPTICAL SENSORS INC WAS APPROACHED BY HOSP STAFF CONCERNING A DISCREPANCY BETWEEN A SENSICATH ARTERIAL BLOOD GAS MEASUREMENT RESULT AND A LABORATORY RESULT FOR A CORRESPONDING SAMPLE. SHE WENT TO THE BEDSIDE AND FOUND THAT A "DEMO" SENSOR WITH "NOT FOR HUMAN USE" LABEL AFFIXED, HAD BEEN ATTACHED FOR PT MONITORING. ARTERIAL BLOOD GAS RESULTS WERE DISPLAYED WITH THE MESSAGE "DEMO RESULTS". DEMO SENSORS ARE NOT STERILE AND DO NOT MEASURE BLOOD GAS. SEVERAL ARTERIAL BLOOD GAS MEASUREMENTS HAD BEEN PERFORMED WHEREIN DEMO RESULTS WERE PRESUMED TO BE ACTUAL. THE DISCREPANCY IN THE LAB COMPARISON WAS FIRST NOTED AFTER MORE THAN 24 HOURS OF MONITORING. THE SENSOR WAS IMMEDIATELY REMOVED AND REPLACED WITH A FUNCTIONING SENSOR, WITH NO ADVERSE EFFECT ON THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SENSICATH ARTERIAL BLOOD GAS SENSOR CCE OPTICAL SENSORS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO VENTILATOR (10/3/1998 TO 10/5/1998).