FDA Adverse Event
Malfunction
Summary report: N
6600
MDR report key: 1992965
·
Received February 8, 2011
Report
- Report Number
- 1720753-2011-01078
- Event Type
- Malfunction
- Date Received
- February 8, 2011
- Date of Event
- January 27, 2011
- Report Date
- February 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE KEY WAS EXTRACTED FROM THE ON/OFF SWITCH. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE KEY TO THE SYSTEM BROKE OFF IN THE ON/OFF SWITCH. NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |