D
Patient 1
NELLCOR PURITAN BENNETT RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE.
MAUDE MDR 871742
- MDR report key
- 871742
- Report number
- 2936999-2007-00280
- Event key
- 0
- Event type
- 3
- Date of event
- 2007-06-01
- Date received
- 2007-06-27
- 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
- RENEE SAAVEDRA-GOMES
- Address
- 4280 HACIENDA DR. PLEASANTON CA 94588 US
- Phone
- 925-925-9255
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | N595 PULSE OXIMETER | PULSE OXIMETER | NELLCOR PURITAN BENNET | DQA | N-595 | N595 | N | R | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-06-27 | 0 |
Event Narratives#
N
Patient 1
THE UNIT WAS REQUESTED BACK FOR INVESTIGATION BUT IT HAS NOT YET BEEN RECEIVED.