DURA-Y SENSOR
Received Feb 20, 2015 · Event occurred Jan 21, 2015
Report 2936999-2015-00159 · MDR key 4533038
Product problems
- Low Test Results
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). CUSTOMER WAS PROVIDED ASSISTANCE TO TROUBLESHOOT FAILURE AND EVERYTHING IS READING AS EXPECTED. PER INFORMATION PROVIDED IN THE OXIMAX DURA-Y DIRECTIONS FOR USE IN REGARDS TO POSSIBLE CAUSES FOR INACCURATE READINGS: WARNINGS: 1) FAILURE TO APPLY THE DURA-Y SENSOR PROPERLY MAY CAUSE INCORRECT MEASUREMENTS. 3) USING THE DURA-Y SENSOR IN THE PRESENCE OF BRIGHT LIGHTS MAY RESULT IN INACCURATE MEASUREMENTS. IN SUCH CASES, COVER THE SENSOR WITH AN OPAQUE MATERIAL. 7) EXCESSIVE MOTION MAY COMPROMISE PERFORMANCE. IN SUCH CASES, TRY TO KEEP THE PATIENT STILL OR CHANGE THE SENSOR SITE TO ONE WITH LESS MOTION. 8) WHEN THE SENSOR IS WRAPPED TOO TIGHTLY OR SUPPLEMENTAL TAPE IS APPLIED, VENOUS PULSATIONS MAY LEAD TO INACCURATE SATURATION MEASUREMENTS. PER PEDICHECK D-YSPD PEDIATRIC SPOT-CHECK CLIP DIRECTIONS FOR USE: WARNINGS: 2) FAILURE TO APPLY THE PEDICHECK SPOT-CHECK CLIP PROPERLY MAY CAUSE INCORRECT MEASUREMENTS. 3) USE OF THE PEDICHECK CLIP WITHOUT THE ELASTIC SLEEVES IN PLACE MAY RESULT IN IMPROPER PLACEMENT WHICH CAN CAUSE INACCURATE MEASUREMENTS. 8) DO NOT ALTER OR MODIFY THE PEDICHECK CLIP OR ITS COMPONENTS. ALTERATIONS OR MODIFICATIONS MAY AFFECT PERFORMANCE OR ACCURACY.
Description of Event or Problem
COVIDIEN RECEIVED A REPORT THAT THE SENSOR READING WAS LOWER THAN WHAT THE PATIENT'S VITALS ACURATELLY WERE. CALLER STATED THERE WAS NO PATIENT HARM IN ASSOCIATION WITH THIS DEVICE.