FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2193115
·
Received July 22, 2011
Report
- Report Number
- 1720753-2011-20300
- Event Type
- Malfunction
- Date Received
- July 22, 2011
- Date of Event
- July 8, 2011
- Report Date
- July 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE BROKEN TANK STRAP FOR THE GROUND AND THE VIDEO WIRE TO THE BACK OF THE LEMO RECEPTACLE WERE 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 INTERMITTENTLY THE SYSTEM DISPLAYED A MILLIAMPERE SENSOR ERROR MESSAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |