FDA Adverse Event
Malfunction
Summary report: N
COVIDIEN NELLCOR
MDR report key: 1982931
·
Received February 3, 2011
Report
- Report Number
- 1982931
- Event Type
- Malfunction
- Date Received
- February 3, 2011
- Date of Event
- February 2, 2011
- Report Date
- February 3, 2011
- Manufacturer
- ASCENT HEALTHCARE SOLUTIONS
- Product Code
- DQA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- FL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PULSE OXIMETER FAILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COVIDIEN NELLCOR | PULSE OXIMETER | DQA | ASCENT HEALTHCARE SOLUTIONS | * | 1412936 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |