FDA Adverse Event
Malfunction
Summary report: N
OXIMAX N-595 PULSE OXIMETER
MDR report key: 2152460
·
Received June 21, 2011
Report
- Report Number
- 2936999-2011-00363
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 26, 2011
- Manufacturer
- COVIDIEN, FORMERLY TYCOHEALTHCARE
- Product Code
- DQA
- PMA / PMN Number
- K012891
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVAL. THE MFG FACILITY PREVIOUSLY INITIATED A CORRECTIVE AND PREVENTATIVE ACTION ASSOCIATED WITH MFG CONFIRMED FAILURES ISOLATED TO THE MAIN PCB. NO FURTHER CONCLUSION CAN BE DRAWN BY THE MFG SITE SINCE THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. INFO 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 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 |