LEVEL 1 GENERAL PURPOSE PROBE
Received Sep 27, 2024 · Event occurred Sep 1, 2024
Report 9617604-2024-00764 · MDR key 20325510
Device
Generic name
Thermometer, Electronic, Clinical
Manufacturer
Smiths Healthcare Manufacturing S.a. De C.v.Catalog number
ER400-9
Lot number
4448623
Product problems
- Device Displays Incorrect Message
- Device Displays Incorrect Message
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED FOR INVESTIGATION. THEREFORE, WE ARE UNABLE TO CONFIRM THE REPORTED COMPLAINT. IF WE RECEIVE THE DEVICE, WE WILL REOPEN THE INVESTIGATION FOR FURTHER EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.
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 THERE WAS A SENSE OF DISCOMFORT IN THE TOUCH OF THE PROBE AS USUAL, AND THE TEMPERATURE WAS DISPLAYED SLIGHTLY LOWER THAN USUAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.