FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2833621
·
Received October 29, 2012
Report
- Report Number
- 1720753-2012-08808
- Event Type
- Malfunction
- Date Received
- October 29, 2012
- Date of Event
- October 15, 2012
- Report Date
- October 29, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE BATTERY PACK WAS REPLACED DURING THE SERVICE CALL. 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 THE SYSTEM SHOWED HIGH VOLTAGE ERRORS AND THE MONITORS DID NOT WORK. THERE IS NO REPORT OF PT INJURY OR DEATH.
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 |