FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 3231029
·
Received July 12, 2013
Report
- Report Number
- 9680959-2013-01368
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 27, 2013
- Report Date
- July 12, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYS AND REPLACED THE INTERCONNECT CABLE. THE SYS OPERATES AS INTENDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYS INTERMITTENTLY WOULD NOT BOOT UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 323136 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |