MalfunctionFLL
PROBE GENERAL PURPOSE 12F
Received Jul 1, 2024 · Event occurred May 28, 2024
Report 3012307300-2024-05673 · MDR key 19651238
Device
Generic name
Thermometer, Electronic, Clinical
Manufacturer
Smiths Medical Asd,incCatalog number
ER400-12
Lot number
4458957
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE DEVICE EXHIBITED INACCURATE TEMPERATURES. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE EVENT/PATIENT HARM REPORTED.
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: THE EFFECTED DEVICE WAS NOT RETURNED. THERE WERE NO PICTURES AVAILABLE FOR REVIEW. WITHOUT THE RETURN OF THE USED SAMPLES, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A PROBABLE CAUSE CANNOT BE DETERMINED.