FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2820354
·
Received October 31, 2012
Report
- Report Number
- 1720753-2012-08919
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 18, 2012
- Report Date
- October 31, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE PS1 POWER SUPPLY VOLTAGE WAS ADJUSTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE FIELD ENGINEER REPORTED THAT THE SYSTEM LOCKED UP AND DISPLAYED A COMMUNICATION FAILURE AND A GENERATOR ERROR MESSAGE. THERE IS NO REPORT OF PT INJURY.
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 |