FDA Adverse Event
Malfunction
Summary report: N
OXIMAX N-595 PULSE OXIMETER
MDR report key: 2062876
·
Received March 21, 2011
Report
- Report Number
- 2936999-2011-00143
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 21, 2011
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- DQA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE CUSTOMER HAS ISOLATED THE FAILURE TO THE MAIN BOARD IN HOUSE. THE MANUFACTURING FACILITY PREVIOUSLY INITIATED A CORRECTIVE AND PREVENTATIVE ACTION ASSOCIATED WITH MANUFACTURING CONFIRMED FAILURES ISOLATED TO THE MAIN PCB. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.
Description of Event or Problem · 1
THE COMPANY RECEIVED A REPORT FROM A BIOMEDICAL ENGINEER THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE. NO PATIENT HARM REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXIMAX N-595 PULSE OXIMETER | PULSE OXIMETER | DQA | COVIDIEN, FORMERLY TYCOHEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |