inforMED
MalfunctionFLL

GENERAL PURPOSE TEMPERATURE PROBE, SOFT

Received Oct 9, 2019 · Event occurred Aug 11, 2019

Report 9172123 · MDR key 9172123

Device

Generic name

Thermometer, Electronic, Clinical

Model number

81-02S412

Product problems

  • Low Test Results

Patient

60 DA

  • Low Blood Pressure/ Hypotension
  • Low Blood Pressure/ Hypotension

Narrative

Description of Event or Problem

PATIENT WAS AN INFANT USING NEW RECTAL TEMPERATURE PROBE FOR MONITORING (AKA GENERAL PURPOSE TEMPERATURE PROBE, SOFT 12 FRENCH, 400 SERIES. REF # 81-02S412). TEMPERATURE WAS CONSISTENTLY READING LOW (35.3 - 35.7C), SO PATIENT WAS PLACED ON A BAIR HUGGER. SUBSEQUENTLY THE PATIENT'S BLOOD PRESSURE BECAME LOWER AND PERFUSION FELT ADEQUATE ALTHOUGH THE MONITOR STILL READ 35.6. TEMP PROBE WAS SWITCHED WITH NO CHANGE IN TEMPERATURE ON MONITOR, SO CABLE WAS SWITCHED AS WELL WITH AGAIN NO CHANGE ON MONITOR. I REPLACED PROBE AND CABLE WITH THE OLDER STYLE AND THE MONITOR THEN READ 37.3, WHICH WAS MUCH MORE IN LINE WITH HOW THE PATIENT APPEARED.