FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2833311
·
Received October 26, 2012
Report
- Report Number
- 1720753-2012-08723
- Event Type
- Malfunction
- Date Received
- October 26, 2012
- Date of Event
- October 12, 2012
- Report Date
- October 26, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE BATTERY CHARGER BOARD WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A CHARGER FAILED ERROR MESSAGE AT START UP. THIS ERROR MESSAGE WILL LIKELY PREVENT THE SYSTEM FROM BOOTING UP. THERE IS NO REPORT OF PT 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 |