FDA Adverse Event
Malfunction
Summary report: N
OXIMAX N-595 PULSE OXIMETER
MDR report key: 2043045
·
Received February 23, 2011
Report
- Report Number
- 2936999-2011-00137
- Event Type
- Malfunction
- Date Received
- February 23, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 24, 2011
- Manufacturer
- COVIDIEN, FORMERLY TYCO HEALTHCARE
- Product Code
- DQA
- PMA / PMN Number
- K012891
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED CUSTOMER COMPLAINT OF "NO AUDIO" WAS CONFIRMED. THE DEVICE WAS RECEIVED AT THE MFG PLANT FOR INVESTIGATION AND THE FAILURE WAS ISOLATED TO THE MAIN PCB. THE MFG FACILITY PREVIOUSLY INITIATED A CORRECTIVE AND PREVENTATIVE ACTION ASSOCIATED WITH THE CONFIRMED FAILURES ISOLATED TO THE MAIN PCB.
Description of Event or Problem · 1
THE COMPANY RECEIVED A REPORT WHERE IT WAS CLAIMED THAT THE UNIT DID NOT PROVIDE AN AUDIO TONE. NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OXIMAX N-595 PULSE OXIMETER | PULSE OXIMETER | DQA | COVIDIEN, FORMERLY TYCO HEALTHCARE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |