FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3113079
·
Received May 9, 2013
Report
- Report Number
- 1720753-2013-05860
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- April 24, 2013
- Report Date
- May 9, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REAL TIME OPERATING SYSTEM WAS REPLACED AND THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE MONITOR DISPLAYED AN INVALID INPUT SIGNAL ERROR MESSAGE AND WOULD NOT COMPLETE BOOT UP. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 204980 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |