FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2913515
·
Received December 21, 2012
Report
- Report Number
- 1720753-2012-10737
- Event Type
- Malfunction
- Date Received
- December 21, 2012
- Date of Event
- December 8, 2012
- Report Date
- December 21, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE POWER CONTROL CABLE WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM EXPERIENCED COMMUNICATION ERRORS. THIS ERROR IS LIKELY TO RESULT IN A SYSTEM LOCK UP OR PREVENT THE SYSTEM FROM BOOTING TO A USABLE STATE. THERE IS NO REPORT OF PT INJURY OR DEATH.
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 |