FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2100218
·
Received May 16, 2011
Report
- Report Number
- 1720753-2011-07349
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- May 2, 2011
- Report Date
- May 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ON SITE INVESTIGATION. THE SVC REP PERFORMED DIAGNOSTIC TESTS AND DETERMINED THE X-RAY TUBE SHOULD BE REPLACED. THE CUSTOMER CANCELED THE SVC CALL. THE REPORTED PROBLEM WAS RESOLVED BY THE CUSTOMER. NO ADDITIONAL SVC INFO WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT PERFORM FLUOROSCOPY AND DISPLAYED A BLACK SCREEN. NO PT INJURY WAS 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 |