FDA Adverse Event
Malfunction
Summary report: N
COROSKOP TOP
MDR report key: 63840
·
Received January 10, 1997
Report
- Report Number
- 2240869-1996-00006
- Event Type
- Malfunction
- Date Received
- January 10, 1997
- Date of Event
- December 11, 1996
- Report Date
- January 10, 1997
- Manufacturer
- SIEMENS MEDICAL SYSTEMS, INC.
- Product Code
- IZI
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
AS THE C-ARM WAS BEING MOVED INTO THE LAO POSITION, THE FILM MAGAZINE FELL OFF THE CINE CAMERA, WHICH IS SUPPLIED WITH THE C-ARM SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COROSKOP TOP | ANGIOGRAPHY FLOUROSCOPIC C-ARM | IZI | SIEMENS MEDICAL SYSTEMS, INC. | 1617450 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |