FDA Adverse Event
Malfunction
Summary report: N
PFM 90
MDR report key: 303741
·
Received November 1, 2000
Report
- Report Number
- 1418957-2000-00006
- Event Type
- Malfunction
- Date Received
- November 1, 2000
- Date of Event
- July 20, 2000
- Report Date
- October 31, 2000
- Manufacturer
- FISCHER IMAGING CORP
- Product Code
- IZI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
WHILE GOING TO MOVE THE X-RAY IT STUCK CAUSING THE WRIST TO JOLT. (EQUIPMENT OPERATOR)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PFM 90 | X-RAY/VASCULAR | IZI | FISCHER IMAGING CORP | 77752 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |