FDA Adverse Event
Malfunction
Summary report: N
OXIMAX N-595 PULSE OXIMETER
MDR report key: 1202048
·
Received October 15, 2008
Report
- Report Number
- 2936999-2008-00505
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Date of Event
- October 13, 2008
- Report Date
- October 13, 2008
- Manufacturer
- COVIDIEN FORMERLY TYCO HEALTHCARE
- Product Code
- DQA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER HAS OPTED TO NOT RETURN THE UNIT IN FOR EVALUATION. THE CUSTOMER HAS ISOLATED THE REPORTED PROBLEM TO THE MAIN PCB. THE MANUFACTURING FACILITY HAS INITIATED A CORRECTIVE AND PREVENTATIVE ACTION ASSOCIATED WITH THE CONFIRMED FAILURE. IF ANY ADDITIONAL INFO IS MADE AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
COVIDIEN FORMERLY TYCO HEALTHCARE RECEIVED 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 |