FDA Adverse Event
Malfunction
Summary report: N
6600
MDR report key: 1973584
·
Received January 19, 2011
Report
- Report Number
- 1720753-2011-00372
- Event Type
- Malfunction
- Date Received
- January 19, 2011
- Date of Event
- December 24, 2010
- Report Date
- January 19, 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 CUSTOMER INDICATED THE REPORTED ISSUE COULD NOT BE DUPLICATED AND THEREFORE CANCELLED THE SERVICE CALL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED AN ERROR CODE MESSAGE AND THEREBY SHUT DOWN. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6600 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |