FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2092791
·
Received May 5, 2011
Report
- Report Number
- 1720753-2011-06972
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- April 18, 2011
- Report Date
- May 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE PS2 POWER SUPPLY WAS REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT AFTER MOVING THE C-ARM SYSTEM, IT DISPLAYED A FAST STOP ERROR MESSAGE. AFTER REBOOTING, IT DISPLAYED A GIB GENERATOR ERROR MESSAGE AND AN INTERLOCK FAILURE ERROR MESSAGE WHICH WOULD NOT RESOLVE AFTER RE-BOOTING THE SYSTEM. NO PT 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 |