MalfunctionFLL
LEVEL 1 GENERAL PURPOSE PROBE
Received Nov 14, 2024 · Event occurred Oct 18, 2024
Report 9617604-2024-00872 · MDR key 20685822
Device
Generic name
Thermometer, Electronic, Clinical
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
ER400-9
Lot number
NI
Product problems
- Overheating of Device
- Overheating of Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 REACHED 40°C WHEN THE PATIENT WAS USING IT, AND IT RETURNED TO NORMAL AFTER CHANGING IT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.