THERMISTOR 400 MON-A-THERM CABLE 400 TM
Received Jul 19, 2017 · Event occurred Jan 1, 2017
Report 2936999-2017-05334 · MDR key 6727128
Device
Generic name
Device, Temperature Measurement, Direct Contact, Powered
Manufacturer
Sinbon Electronics-jiangyinModel number
5020410ACatalog number
5020410A
Product problems
- Contamination
- Contamination
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
ON (B)(6) 2017 MEDTRONIC RECEIVED NOTIFICATION OF AN INTERFACE CABLE WAS THOUGHT TO BE CONTAMINATED WITH PATHOGENS IN THE ICU. FOLLOW UP EFFORTS ARE BEING MADE TO COLLECT FURTHER INFORMATION RELATED TO THE CIRCUMSTANCES OF THIS REPORT. UPDATES WILL BE PROVIDED IN A FOLLOW-UP REPORT.
Additional Manufacturer Narrative
THE INFORMATION PROVIDED INDICATES THAT THE SAMPLE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IF THE SAMPLE IS RETURNED, A SUMMARY OF THE ANALYSIS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
(B)(6)2017 MEDTRONIC RECEIVED NOTIFICATION OF AN INTERFACE CABLE WAS THOUGHT TO BE CONTAMINATED WITH PATHOGENS IN THE ICU. FOLLOW UP EFFORTS ARE BEING MADE TO COLLECT FURTHER INFORMATION RELATED TO THE CIRCUMSTANCES OF THIS REPORT. UPDATES WILL BE PROVIDED IN A FOLLOW-UP REPORT.