TIR-1 THERMOMETER
Received Apr 27, 2023 · Event occurred Mar 18, 2023
Report 3019388613-2023-00133 · MDR key 16828504
Device
Generic name
Thermometer, Electronic, Clinical
Manufacturer
Masimo - 15750 Alton PkwyModel number
4301Catalog number
4301
Product problems
- Low Readings
- Low Readings
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE CUSTOMER REPORTED THE TIR-1 THERMOMETER "READ 97.9 AT TWO SEPARATE TIMES. PATIENT FELT PHYSICALLY HOTTER TO TOUCH. RECTAL TEMPERATURE SUBSEQUENTLY TAKEN AND RESULTED AT 100.6 AND 100.3 RESPECTIVELY." NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.
Additional Manufacturer Narrative
ADDITIONAL MANUFACTURING NARRATIVE: ATTEMPTS HAVE BEEN MADE TO OBTAIN THE PRODUCT. THE PRODUCT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE PRODUCT IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. H3 OTHER TEXT : PRODUCT NOT RETURNED.
Remedial action
- Other