FDA Adverse Event
Injury
Summary report: N
SIEMENS - COROSKOP
MDR report key: 175649
·
Received June 30, 1998
Report
- Report Number
- 175649
- Event Type
- Injury
- Date Received
- June 30, 1998
- Date of Event
- April 15, 1998
- Report Date
- April 29, 1998
- Manufacturer
- SIEMENS
- Product Code
- IZO
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
REPORT OF INCIDENT CALLED TO COMPANY 4/15/98. SIEMENS XRAY EQUIPMENT WENT DOWN AND WOULD NOT REBOOT. PT HAD INTROCORONARY WIRE PLACED AND HAD TO BE MOVED TO ANOTHER LAB. THROMBUS DEVELOPED IN VESSEL BUT RESOLVED WITHOUT INJURY TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SIEMENS - COROSKOP | X RAY EQUIP. | IZO | SIEMENS | COROSKOP | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Life Threatening |