BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSCUTANEOUS BLOOD GAS MONITOR

    MDR report key: 4260898 · Received November 15, 2014

    Report

    Report Number
    3002807968-2014-00057
    Event Type
    Malfunction
    Date Received
    November 15, 2014
    Report Date
    October 14, 2016
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    LKD
    PMA / PMN Number
    K093154
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIMULATOR TEST HAS BEEN PERFORMED WITH THE COMBIM MONITOR AND THE TEST WAS PASSED. THE SENSOR ELECTRODE HAS BEEN REQUESTED SENT BACK TO RADIOMETER FOR INVESTIGATION BUT IT HAS NOT YET BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    THE SENSOR ELECTRODE WAS SENT BACK TO RADIOMETER FOR INVESTIGATION. THE RESULT OF THE INVESTIGATION WAS THAT THE SENSOR ELECTRODE WAS WORKING AS INTENDED.

    Additional Manufacturer Narrative · 1

    DURING AN INTERNAL REVIEW OF THIS CASE, IT WAS DISCOVERED THAT THE MODEL AND CATALOG NUMBER WAS STATED INCORRECTLY IN THE INITIAL REPORT AND FOLLOW-UP REPORT NO 1.

    Description of Event or Problem · 1

    THE TCM COMBIM WAS READING TOO HIGH WHEN MONITORING A PT. READINGS WERE 80-90 MMHG AND CONTINUED TO GO HIGHER. AS A CONSEQUENCE THE PATIENT (A PRE-TERM INFANT) RECEIVED TREATMENT CONSISTING IN "BAGGING" TO BRING CO2 DOWN. IT IS STATED IN THE COMPLAINT THAT THERE WAS NO HARM TO THE PT AS RESULT OF THE TREATMENT. LATER A BLOOD SAMPLE FROM THE PT WAS TESTED FOR CO2 WITH RESULT OF 36 MMHG. AT THAT TIME THE TCM COMBIM WAS READING 130 MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740759 TRANSCUTANEOUS BLOOD GAS MONITOR TCM TOSCA/COMBIM LKD RADIOMETER MEDICAL APS TCM TOSCA/COMBIM

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA Other