FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 1913595
·
Received November 12, 2010
Report
- Report Number
- 1720753-2010-04048
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 26, 2010
- Report Date
- November 12, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE CAMERA AND IMAGE INTENSIFIER WERE CLEANED DURING THE SVC CALL. THE IMAGE INTENSIFIER AND CCD CAMERA SHOULD BE REPLACED, BUT THE CUSTOMER HAS ELECTED TO USE THE SYS AS IT IS AT THIS TIME. THE SYS IS OPERATING WITH A DEGRADED IMAGE QUALITY, BUT IT MEETS MINIMUM SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9600 SYS HAD POOR IMAGE QUALITY WITH WASHED OUT IMAGES DURING A CASE. THE PROCEDURE WAS COMPLETED WITH ANOTHER SYS. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |