D
Patient 1
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.
MAUDE MDR 4533038
- MDR report key
- 4533038
- Report number
- 2936999-2015-00159
- Event key
- 0
- Event type
- 3
- Date of event
- 2015-01-21
- Date received
- 2015-02-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 0
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- DENISE BRAXTON
- Address
- 6135 GUNBARREL AVE BOULDER 80301 US
- Phone
- 303-303-3038
- Report source
- M
- Manufacturer link flag
- Y
Devices#
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-02-20 | 0 |
Event Narratives#
N
Patient 1
(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.