FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3050443
·
Received April 8, 2013
Report
- Report Number
- 1720753-2013-04724
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 29, 2013
- Report Date
- April 8, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE CONNECTORS WERE REGREASED, A FILAMENT CALIBRATION WAS PERFORMED AND THE (B)(4) SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WAS OVERHEATING AND CUTTING ON AND OFF. THE SYSTEM WAS SHUTTING DOWN WITHOUT COMMAND. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142481 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |