FDA Adverse Event
Malfunction
Summary report: N
9600EMI
MDR report key: 1040807
·
Received May 9, 2008
Report
- Report Number
- 1720753-2008-21390
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 25, 2008
- Report Date
- May 8, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED SYSTEM WILL NOT BOOT UP AT ALL. PT HAD BEEN ON THE TABLE, BUT THE PT WAS NOT INJURED. THE CUSTOMER WAS NOT ABLE TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600EMI | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |