FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4110631
·
Received September 16, 2014
Report
- Report Number
- 1720753-2014-07922
- Event Type
- Malfunction
- Date Received
- September 16, 2014
- Date of Event
- August 20, 2014
- Report Date
- September 16, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE POWER SUPPLY CONNECTION WAS REPAIRED AND THE POWER SUPPLY WAS ADJUSTED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THE SYSTEM DISPLAYED AN INTERMITTENT COMMUNICATION CAUSING THE SYSTEM TO LOCK UP. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THE COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 572299 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |