FDA Adverse Event
Malfunction
Summary report: N
OXIMAX N-595 PULSE OXIMETER
MDR report key: 2020550
·
Received February 10, 2011
Report
- Report Number
- 2936999-2011-00093
- Event Type
- Malfunction
- Date Received
- February 10, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 10, 2011
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- DQA
- PMA / PMN Number
- K012891
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. THE SVC HISTORY RECORD FOR THIS DEVICE WAS REVIEWED FOR SIMILAR COMPLAINT MODES. NO RELEVANT COMPLAINT MODES WERE FOUND IN THE DEVICE SVC HISTORY RECORD. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. NO FURTHER CONCLUSION CAN BE DRAWN BY THE MFG SITE SINCE THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS.
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 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 TYCOHEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |