FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2884967
·
Received December 4, 2012
Report
- Report Number
- 1720753-2012-10034
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Date of Event
- November 13, 2012
- Report Date
- December 4, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM BATTERIES WERE DIAGNOSED AS BEING DEFECTIVE. THE CUSTOMER ORDERED REPLACEMENT BATTERIES. NO FURTHER REPAIR INFORMATION IS AVAILABLE AT THIS TIME.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A PRECHARGE VOLTAGE ERROR MESSAGE AN WOULD NOT BOOT UP. THERE IS NO REPORT OF PATIENT 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 |