FDA Adverse Event
Death
Summary report: N
9800
MDR report key: 2000404
·
Received February 16, 2011
Report
- Report Number
- 1720753-2011-01368
- Event Type
- Death
- Date Received
- February 16, 2011
- Date of Event
- December 15, 2010
- Report Date
- February 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT EXHIBITED IN THE OPERATING ROOM WITH A RUPTURED AORTIC ANEURYSM. THE PATIENT EXPIRED 24 HOURS LATER POST OPERATIVELY, SECONDARY TO BLOOD LOSS. A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED AN OVERLOAD FAULT ERROR CODE AND THEREBY SHUT DOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Death |