D
Patient 1
IT WAS REPORTED SENSOR SHOWED OF 56-60 % WITH A NELLCOR HANDHELD MONITOR (MODEL AND SERIAL NUMBER IS UNKNOWN). COVIDIEN HAS ATTEMPTED TO GATHER FURTHER DETAILS SURROUNDING THE CIRCUMSTANCES OF THIS REPORT, WITHOUT SUCCESS.
MAUDE MDR 4226639
- MDR report key
- 4226639
- Report number
- 2936999-2014-00962
- Event key
- 0
- Event type
- 3
- Date received
- 2014-11-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- DENISE BRAXTON
- Address
- 6135 GUNBARRELL AVE. BOULDER CO 80301 US
- Phone
- 303-303-3038
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-11-05 | 0 |
Event Narratives#
N
Patient 1
(B)(4). NO SAMPLE IS EXPECTED TO BE RETURNED. WITHOUT THE ACTUAL COMPLAINT SAMPLE A FULL INVESTIGATION CANNOT BE COMPLETED THEREFORE WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT. PER INFORMATION PROVIDED IN THE OXIMAX DURA-Y DIRECTIONS FOR USE IN REGARDS TO POSSIBLE CAUSES FOR INACCURATE READINGS: WARNINGS: FAILURE TO APPLY THE DURA-Y SENSOR PROPERLY MAY CAUSE INCORRECT MEASUREMENTS. 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. EXCESSIVE MOTION MAY COMPROMISE PERFORMANCE. IN SUCH CASES, TRY TO KEEP THE PATIENT STILL OR CHANGE THE SENSOR SITE TO ONE WITH LESS MOTION. WHEN THE SENSOR IS WRAPPED TOO TIGHTLY OR SUPPLEMENTAL TAPE IS APPLIED, VENOUS PULSATIONS MAY LEAD TO INACCURATE SATURATION MEASUREMENTS.