PROBE, GENERAL PURPOSE 9F 20/BX
Received Sep 17, 2024 · Event occurred Aug 14, 2024
Report 9617604-2024-00725 · MDR key 20239993
Device
Generic name
Thermometer, Electronic, Clinical
Manufacturer
Icu Medical, IncCatalog number
ER400-9
Lot number
UNKNOWN
Product problems
- Temperature Problem
- Temperature Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DEVICE EVALUATION: ONE DEVICE WAS RECEIVED FOR DEVICE ANALYSIS. SERVICE HISTORY REVIEW IDENTIFIED THE COMPLAINT WAS NOT RELATED TO A PREVIOUS SERVICE OF THE DEVICE WITHIN THE REVIEW PERIOD. FUNCTIONAL TESTING AND VISUAL INSPECTION PERFORMED DURING ANALYSIS. THE CUSTOMER REPORTED COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE WAS UNABLE TO BE DETERMINED.
Additional Manufacturer Narrative
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THAT THE TEMPERATURE DISPLAYED ON THE MONITOR SUDDENLY ROSE FROM 36.6°C TO 41.1°C. THE DEVICE WAS IMMEDIATELY REPLACED WITH A NEW TEMPERATURE PROBE AND IT WAS AROUND 36.6°C. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.