BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-CATH

    MDR report key: 8835787 · Received July 29, 2019

    Report

    Report Number
    8835787
    Event Type
    Malfunction
    Date Received
    July 29, 2019
    Date of Event
    June 19, 2019
    Report Date
    June 19, 2019
    Manufacturer
    CIRCA SCIENTIFIC, LLC
    Product Code
    FLL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    CIRCA TEMPERATURE PROBE (ESOPHAGEAL TEMPERATURE PROBE) WAS PLACED BY ANESTHESIA BUT IT WOULDN'T SHOW POLES 5&6 MESSAGE NOTING INOPERABLE. IT WAS REPLACED WITH A NEW ONE AND WORKED FINE (SAME LOT NUMBER). THE PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630958 S-CATH THERMOMETER, ELECTRONIC, CLINICAL FLL CIRCA SCIENTIFIC, LLC 13588-01

    Patients

    Seq Age Sex Outcome Treatment
    1