FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2934253
·
Received January 7, 2013
Report
- Report Number
- 1720753-2013-00241
- Event Type
- Malfunction
- Date Received
- January 7, 2013
- Date of Event
- November 28, 2012
- Report Date
- January 7, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC0
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SURGE SUPPRESSOR, POWER CONTROL AND SMART SWITCH CIRCUIT BOARDS WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT TURN ON. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8444 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC0 | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |