FDA Adverse Event
Injury
Summary report: N
SIEMENS MEDICAL SYSTEMS INC.
MDR report key: 25573
·
Received August 8, 1995
Report
- Report Number
- 25573
- Event Type
- Injury
- Date Received
- August 8, 1995
- Date of Event
- March 6, 1995
- Report Date
- March 16, 1995
- Manufacturer
- SIEMENS MED SYSTEMS, INC.
- Product Code
- IYB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 3/6/95, WHILE SETTING UP FOR A PERI/DSA STUDY, THE TECHNOLOGIST MISTAKENLY HIT "PERI". HE PROCEEDED TO SET FILTERS, ETC. AND LEFT THE GANTRY AT THE FOOT POSITION WITH FLUORO IN PLACE. A PERI/DSA PROTOCOL WAS ON THE FIRST MONITOR. THE DSA ACQUISITION BUTTON WAS ACTIVATED, THE FIRST EXPOSURE WAS TAKEN--ABOUT FOUR/FRAMES/SEC; THEN THE INJECTOR FIRED AND GAVE THE PT FULL CONTRAST DOSE. ON 3/7/95, THE PT WENT INTO RENAL FAILURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIEMENS MEDICAL SYSTEMS INC. | STEPPING GANTRY | IYB | SIEMENS MED SYSTEMS, INC. | 9359142G127E |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Hospitalization| R |