FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3013134
·
Received March 1, 2013
Report
- Report Number
- 1720753-2013-03244
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- February 12, 2013
- Report Date
- March 1, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AG
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND RESEATED CIRCUIT BOARDS CABLES, AND CONNECTORS. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM DISPLAYED A COMMUNICATION ERROR. THIS ERROR WILL CAUSE THE SYSTEM TO LOCKUP, SHUT DOWN, OR NOT TO BOOT. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89986 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |