FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 1970098
·
Received January 14, 2011
Report
- Report Number
- 1720753-2011-00302
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- December 16, 2010
- Report Date
- January 14, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE TABLE EXTENSION AND LEFT SIDE LATCH BRACKET WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM'S FOOT EXTENSION FAILED TO OPERATE PROPERLY. NO REPORT OF PT OR STAFF INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |