FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2940986
·
Received January 31, 2013
Report
- Report Number
- 1720753-2013-01316
- Event Type
- Malfunction
- Date Received
- January 31, 2013
- Date of Event
- January 24, 2013
- Report Date
- January 31, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN OVER-THE-PHONE INVESTIGATION. THE CUSTOMER WAS INSTRUCTED TO PRESS THE FAST STOP SWITCH SEVERAL TIMES TO RESTORE CONTACT. THERE IS NO REPORT OF PT INJURY.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYS DISPLAYED A "LOCKING MECHANISM DEFECTIVE" ERROR MESSAGE AND NO EXPOSURE WAS POSSIBLE. THE SYS WAS LOCKED UP. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 42156 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |