FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3921418
·
Received May 21, 2014
Report
- Report Number
- 1720753-2014-04454
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Date of Event
- May 15, 2014
- Report Date
- May 23, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE FAILURE COULD NOT BE DUPLICATED. THE CINE CABLE AND INTERCONNECT CABLE WERE EVALUATED AND 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 FREEZES DURING EXAMS. THIS CAUSED AN INTERMITTENT, RECOVERABLE LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303369 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |