FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2040589
·
Received March 22, 2011
Report
- Report Number
- 1720753-2011-02597
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- February 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN, AS REPAIR INFO IS UNAVAILABLE; HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED. NO FURTHER INFO IS AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 2800 SYSTEM OVERHEAD X-RAY ARM WOULD NOT MOVE AND CAUSED THE SYSTEM TO LOCK UP WITH TOTAL LOSS OF IMAGING FUNCTIONALITY. 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 |