FDA Adverse Event
Malfunction
Summary report: N
ACIST
MDR report key: 504826
·
Received December 27, 2003
Report
- Report Number
- MW1030656
- Event Type
- Malfunction
- Date Received
- December 27, 2003
- Date of Event
- December 26, 2003
- Report Date
- December 27, 2003
- Manufacturer
- ACIST MEDICAL SYSTEMS
- Product Code
- IZQ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OR, US
- Reporter Occupation
- RADIOLOGIC TECHNOLOGIST
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACIST | CONTRAST INJECTOR | IZQ | ACIST MEDICAL SYSTEMS | CP101 (DISPLAY) | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |