FDA Adverse Event
Malfunction
Summary report: N
OXIMAX N-595 PULSE OXIMETER
MDR report key: 1182652
·
Received September 24, 2008
Report
- Report Number
- 2936999-2008-00460
- Event Type
- Malfunction
- Date Received
- September 24, 2008
- Date of Event
- September 19, 2008
- Report Date
- September 19, 2008
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEALTHCARE
- Product Code
- DQA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE ASSOCIATED WITH THIS REPORT WAS REQUESTED BACK FOR EVAL, BUT IT HAS NOT YET BEEN REC'D.
Description of Event or Problem · 1
COVIDIEN FORMERLY TYCO HEALTHCARE REC'D A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE. THERE WAS NO PT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXIMAX N-595 PULSE OXIMETER | PULSE OXIMETER | DQA | COVIDIEN, FORMERLY TYCO HEALTHCARE | N-595 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |