FDA Adverse Event
Malfunction
Summary report: N
NELLCOR OXIMAX N-65
MDR report key: 3243036
·
Received July 18, 2013
Report
- Report Number
- 2936999-2013-00507
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Date of Event
- June 20, 2013
- Report Date
- June 20, 2013
- Manufacturer
- SANMINA - SCI SYSTEMS
- Product Code
- DQA
- PMA / PMN Number
- K051352
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
COVIDIEN SERVICE CENTER CONFIRMED THE COMPLAINT. THE UI PCB WAS REPLACED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE UNIT'S DISPLAY WAS MISSING SEGMENTS ON THE LCD. NO PT HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336413 | NELLCOR OXIMAX N-65 | PULSE OXIMETER | DQA | SANMINA - SCI SYSTEMS | N-65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |