FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2022271
·
Received February 28, 2011
Report
- Report Number
- 1720753-2011-01735
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- February 9, 2011
- Report Date
- February 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE REP PERFORMED AN ON SITE INVESTIGATION. THE CONNECTOR WAS TIGHTENED AND THE BELT TENSION ON THE ORBITAL POTENTIOMETER WAS ADJUSTED. THE SYS WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYS DISPLAYED A MOTION ERROR MESSAGE. NO REPORT OF PT INJURY.
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 |