FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2022248
·
Received February 28, 2011
Report
- Report Number
- 1720753-2011-01718
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 28, 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
THE MANUFACTURER'S SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REP COULD NOT DUPLICATE THE REPORTED PROBLEM. THE SERVICE REP RE-STRAPPED THE ISOLATION TRANSFORMER FOR A DIFFERENT OUTLET THAT HAD A STABLE POWER SOURCE. THE SYSTEM WAS TESTED AND OPERATED AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM IS ALARMING WHEN THE DEVICE IS OFF. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |