FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2243667
·
Received August 24, 2011
Report
- Report Number
- 1720753-2011-21328
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 19, 2011
- Report Date
- August 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE EVALUATION. THE SERVICE REPRESENTATIVE ADVISED THE CUSTOMER TO REPLACE THE BATTERIES. NO FURTHER SERVICE INFORMATION IS AVAILABLE SO NO CONCLUSION CAN BE DRAWN.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE BATTERY CHARGER INDICATED "OVER VOLTAGE". NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |