FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1188900
·
Received October 8, 2008
Report
- Report Number
- 1720753-2008-25213
- Event Type
- Malfunction
- Date Received
- October 8, 2008
- Date of Event
- August 15, 2008
- Report Date
- August 28, 2004
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP ADJUSTED THE STOP IRIS FOR DIGISPOT. HE CHECKED VOLTAGES AND VERIFIED TRACKING. ALL WERE OK. HE VERIFIED SYSTEM IS OPERATING BY FLOUROING IN LOW AND HIGH TECHNIQUE, BEFORE RETURNING BACK TO THE CUSTOMER AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE IMAGE WAS GETTING LIGHT AND DARK. THE CUSTOMER RESET SYSTEM AND IT BEGAN OPERATING CORRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |