FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2152573
·
Received June 22, 2011
Report
- Report Number
- 1720753-2011-08426
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- June 7, 2011
- Report Date
- June 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION AND REPLACED THE PS4 POWER SUPPLY AND ROTATIONAL CONTROLLER. THE ROTATIONAL AND ORBITAL POTENTIOMETERS AND THE REMOTE USER INTERFACE WERE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A MOTION ERROR MESSAGE OUTSIDE OF A PROCEDURE. 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 |