FDA Adverse Event
Malfunction
Summary report: N
2600
MDR report key: 2934293
·
Received January 7, 2013
Report
- Report Number
- 1720753-2013-00270
- Event Type
- Malfunction
- Date Received
- January 7, 2013
- Date of Event
- November 26, 2012
- Report Date
- January 7, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND RESEATED CIRCUIT BOARDS AND CONNECTORS, AND ADJUSTED THE 5 VOLT POWER SUPPLY. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM HAD MULTIPLE ERRORS AND SYMPTOMS AND INTERMITTENTLY LOCKED UP. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 8655 | 2600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |