FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3201319
·
Received June 26, 2013
Report
- Report Number
- 1720753-2013-07619
- Event Type
- Malfunction
- Date Received
- June 26, 2013
- Date of Event
- June 18, 2013
- Report Date
- June 26, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CINE BRIDGE BOARD WAS REPLACED AND THE CINE DRIVE WAS REFORMATTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE CINE RUNS COULD NOT BE VIEWED BECAUSE OF CONTINUED FLASHING. THE IMAGE QUALITY AND/OR FLASHING WAS SO DEGRADED THE SYSTEM WAS UNUSABLE FOR VIEWING CINE PLAYBACK. THERE IS NO REPORT OF PT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 289481 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |