FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2023048
·
Received February 24, 2011
Report
- Report Number
- 1720753-2011-01614
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- February 10, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE FAULT WAS DUPLICATED AS THE MONITOR SETTINGS JUMP TO MAXIMUM AND THERE IS NO IMAGE. THE FUSE ON THE SNUBBER BOARD WAS CHECKED AND FOUND TO BE IN WORKING CONDITION. THE ENGINEER ALSO CONFIRMED THE SYSTEM WAS PRODUCING X-RAYS. A PINCHED VIDEO LINE WAS FOUND AT THE CAMERA. THE LINE WAS UNFOLDED. THE SYSTEM WAS TESTED AND OPERATED AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTS THE 9800 SYSTEM'S MONITOR BLANKS OUT. NO PT INJURY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |