NELLCOR
Received Nov 29, 2016
Report 2936999-2016-00986 · MDR key 6132938
Product problems
- Incorrect Or Inadequate Test Results
Patient
57 YR
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
COVIDIEN/MEDTRONIC REFERENCE NUMBER (B)(4). PATIENT INFORMATION (ID, WEIGHT) AS WELL AS ADDITIONAL INFORMATION ASSOCIATED WITH THE COMPLAINT HAVE BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem
THE CUSTOMER REPORTED THE PATIENT WAS WARM AND PERIPHERALLY WELL PERFUSED AND THE DS100A WAS READING AN SP02 OF 100%. THE ABG (ARTERIAL BLOOD GAS) RESULT AT THE SAME TIME ON THE SAME PATIENT, INDICATED A SAO2 OF 80%. THEY REMOVED AND REPLACED THE DS100A WITH A MAXAI SP02 SENSOR AND THE READINGS WERE WAS MORE ACCURATE. THERE WAS NO PATIENT HARM REPORTED.