FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2040642
·
Received March 22, 2011
Report
- Report Number
- 1720753-2011-02650
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- February 21, 2011
- Report Date
- March 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND DETERMINED THE GENERATOR INTERFACE BOARD AND THE FLUORO FUNCTIONS BOARD NEED TO BE REPLACED. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM INTERMITTENTLY WOULD NOT BOOT UP. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |