FDA Adverse Event
Malfunction
Summary report: N
NELLCOR OXIMAX N-65
MDR report key: 3032682
·
Received March 29, 2013
Report
- Report Number
- 2936999-2013-00204
- Event Type
- Malfunction
- Date Received
- March 29, 2013
- Date of Event
- March 6, 2013
- Report Date
- March 6, 2013
- Manufacturer
- SANMINA-SCI SYSTEMS
- Product Code
- DQA
- PMA / PMN Number
- K051352
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER'S COMPLAINT WAS VERIFIED. ISOLATED TO THE UI BOARD. THE UI BOARD WAS REPLACED AND PASSED TESTING.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN THAT THE UNIT HAS MISSING DISPLAY SEGMENTS IN THE SPO2 THIRD WINDOW BOTTOM CHARACTER. THERE WAS NO PT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 131213 | NELLCOR OXIMAX N-65 | PULSE OXIMETER | DQA | SANMINA-SCI SYSTEMS | N-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |