D
Patient 1
THE COMPANY RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE.
MAUDE MDR 1353288
- MDR report key
- 1353288
- Report number
- 2936999-2009-00086
- Event key
- 0
- Event type
- 3
- Date of event
- 2009-01-01
- Date received
- 2009-02-18
- 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
- HOLLY GOMES, QA SUPERVISOR
- Address
- 5870 STONERIDGE DR. SUITE 6 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 | OXIMAX N595 PULSE OXIMETER | PULSE OXIMETER | COVIDIEN, FORMERLY TYCOHEALTHCARE | DQA | N595 | R | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2009-02-18 | 0 |
Event Narratives#
N
Patient 1
THE CUSTOMER HAS ISOLATED THE FAILURE TO THE MAIN BOARD. THE MONITOR WILL BE RETURNED FOR FAILURE INVESTIGATION. IF NEW INFORMATION IS IDENTIFIED RELATED TO THE REPORTED FAILURE A SUPPLEMENTAL REPORT WILL BE PROVIDED.