FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3060854
·
Received April 5, 2013
Report
- Report Number
- 1720753-2013-04667
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- March 22, 2013
- Report Date
- April 5, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SAFETY CIRCUIT AND INTERNAL WIRING WAS REPAIRED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY ERROR MESSAGES AND THEN FREEZE (LOCK UP). INVESTIGATION DETERMINED THE SYSTEM WAS SHUTTING DOWN UNEXPECTEDLY. THERE IS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 141929 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |