N
Patient 1
(B)(4). (B)(4) IS THE IMPORTER OF RECORD FOR THIS DEVICE. THE LEGAL MANUFACTURER (NOX MEDICAL) HAS BEEN NOTIFIED OF THE REPORTED EVENT. ANY FURTHER REPORTS WILL COME FROM THE LEGAL MANUFACTURER.
MAUDE MDR 6028465
- MDR report key
- 6028465
- Report number
- 2021710-2016-04638
- Event key
- 0
- Event type
- 3
- Date of event
- 2016-09-20
- Date received
- 2016-10-13
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 114
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Report source
- D
- Manufacturer link flag
- N
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NOX T3, NOXTURNAL | VENTILATORY EFFORT RECORDER | NOX MEDICAL | MNR | T3 SLEEP MONITOR | 22857-001 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-10-13 | 0 | 1. O |
Event Narratives#
D
Patient 1
THE CUSTOMER REPORTED THAT WHILE THEIR PATIENT WAS WEARING THE T3 NONIN 3150 PULSE OXIMETER THE PATIENT REPORTED A BUMP AND BURN ON THEIR LEFT FINGER. THE PATIENT HAS NOT BEEN SEEN BY ANY MEDICAL PROFESSIONAL ABOUT THE BURN TO DATE. THE CUSTOMER BELIEVES THAT THEIR PATIENT'S ISSUE WAS DUE TO THE RED LIGHT IN THE FINGER PROBE. THE DEVICE WAS RETURNED TO THE CUSTOMER BY THE PATIENT.