FDA Adverse Event
Malfunction
Summary report: N
PCA
MDR report key: 3201099
·
Received April 26, 2013
Report
- Report Number
- 3201099
- Event Type
- Malfunction
- Date Received
- April 26, 2013
- Date of Event
- March 25, 2013
- Report Date
- April 26, 2013
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 183362 | PCA | PUMP, INFUSION | FRN | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR |