FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2903362
·
Received December 14, 2012
Report
- Report Number
- 1720753-2012-10476
- Event Type
- Malfunction
- Date Received
- December 14, 2012
- Date of Event
- December 5, 2012
- Report Date
- December 14, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE POWER SUPPLY, POWER SUPPLY CABLING AND GENERATOR INTERFACE BOARD WERE 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 COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR MESSAGE WILL LIKELY RESULT IN A SYSTEM LOCK UP. NO BOOT, OR SHUT DOWN DEPENDING ON WHEN THE LOSS OF COMMUNICATION OCCURS. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |