SKIN TEMPERATURE PROBE, 400 SERIES
Received Aug 12, 2024 · Event occurred May 15, 2024
Report 9613793-2024-00003 · MDR key 19960641
Device
Generic name
Thermometer, Electronic, Clinical
Manufacturer
Deroyal Cientifica De Latinoamerica S.r.lModel number
81-010400Lot number
60393328
Product problems
- Device Sensing Problem
- Device Sensing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A USER FACILITY REPORTED, " PRE-OP PATIENT TEMP IS TAKEN MANUALLY. INTRA-OP PATIENT TEMP IS MONITORED BY DEROYAL'S SKIN TEMP SENSOR IN AXILLARY LOCATION, ROUTINELY OFF BY 4 DEGREES. POST-OP TEMP IS TAKEN MANUALLY." DEROYAL HAS REQUESTED RETURN OF A SAMPLE, BUT IT HAS NOT YET BEEN PROVIDED. THE INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
A USER FACILITY REPORTED, " PRE-OP PATIENT TEMP IS TAKEN MANUALLY. INTRA-OP PATIENT TEMP IS MONITORED BY DEROYAL'S SKIN TEMP SENSOR IN AXILLARY LOCATION, ROUTINELY OFF BY 4 DEGREES. POST-OP TEMP IS TAKEN MANUALLY. "
Additional Manufacturer Narrative
A USER FACILITY REPORTED, " PRE-OP PATIENT TEMP IS TAKEN MANUALLY. INTRA-OP PATIENT TEMP IS MONITORED BY DEROYAL'S SKIN TEMP SENSOR IN AXILLARY LOCATION, ROUTINELY OFF BY 4 DEGREES. POST-OP TEMP IS TAKEN MANUALLY." DEROYAL REQUESTED RETURN OF A SAMPLE AND RECEIVED IT ON MAY 11, 2024. THE SAMPLE WAS TESTED ACCORDING TO THE SPECIFICATIONS AND CONFIRMED TO BE WITHIN THE DESIGNATED SPECS. THE DEVICE HISTORY RECORD FOR THE DEVICE WAS REVIEWED AND IT WAS CONFIRMED THAT NO ISSUES WERE NOTED IN MANUFACTURING OR INSPECTION. SUBASSEMBLY LOTS OF THE DEVICE WERE ALSO REVIEWED AND NO FUNCTIONAL ISSUES WERE FOUND. INVENTORY OF 125 EACHES WERE INSPECTED AND NO FUNCTIONAL ISSUES WERE IDENTIFIED. RISK DOCUMENTS AND MATERIAL REVIEW REPORTS WERE REVIEWED AND DID NOT REQUIRE ANY UPDATES OR ADDITIONS. (B)(4). ROOT CAUSE: BECAUSE NO ISSUES WERE FOUND WITH THE RETURNED SAMPLE OR DOCUMENTATION OF THE MANUFACTURING PROCESS, NO ROOT CAUSE COULD BE DETERMINED. CORRECTIVE AND PREVENTIVE ACTION: BECAUSE NO ROOT CAUSE COULD BE ESTABLISHED, NO CORRECTIVE OR PREVENTIVE ACTIONS WERE TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.