FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3070108
·
Received April 15, 2013
Report
- Report Number
- 1720753-2013-04940
- Event Type
- Malfunction
- Date Received
- April 15, 2013
- Date of Event
- March 29, 2013
- Report Date
- April 15, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS(SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HARD DRIVE WAS REPLACED AND THE SYSTEM 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 DISPLAYED AN "ERROR DETECTED AT BOOT UP" THAT KEPT SAYING TO TURN THE SYSTEM OFF AND BACK ON AGAIN. THIS PREVENTED THE SYSTEM FROM BOOTING UP. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 161861 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS(SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |