FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2820559
·
Received November 2, 2012
Report
- Report Number
- 1720753-2012-09019
- Event Type
- Malfunction
- Date Received
- November 2, 2012
- Date of Event
- October 29, 2012
- Report Date
- November 2, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CMOS BATTERY WAS REPLACED, THE REAL TIME OPERATING SYSTEM BOARD WAS REINSTALLED 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 THERE WAS AN ARCNET COMMUNICATION ISSUE AND THE SYSTEM WOULD NOT BOOT UP. THERE IS NO REPORT OF PATIENT 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 |