FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2994171
·
Received February 13, 2013
Report
- Report Number
- 1720753-2013-01731
- Event Type
- Malfunction
- Date Received
- February 13, 2013
- Date of Event
- January 25, 2013
- Report Date
- February 13, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE B+ BATTERIES WERE REPLACED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYS WAS DISPLAYING OVER VOLTAGE ERROR MESSAGES, THE TUBE WAS MAKING LOUD POPPING NOISE AND THE SCREEN WAS GOING BLACK. AN ALTERNATE SYSTEM WAS REQUIRED TO COMPLETE THE CASE. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63885 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |