FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2030192
·
Received March 7, 2011
Report
- Report Number
- 1720753-2011-01967
- Event Type
- Malfunction
- Date Received
- March 7, 2011
- Date of Event
- February 25, 2011
- Report Date
- March 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REP PERFORMED AN ONSITE INVESTIGATION. THE LOCKING ASSEMBLY WAS REPAIRED AND THE LEG EXTENSION WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE BED ON THE 2800 SYSTEM WOULD NOT LOCK AND THAT THE LEG EXTENSION CANNOT BE REMOVED FROM THE TABLE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |