FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2072430
·
Received April 8, 2011
Report
- Report Number
- 1720753-2011-03462
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- July 23, 2010
- Report Date
- April 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE DISABLED THE EXTENDED FLUOROSCOPY AND COULD NOT DUPLICATE THE INCOMPLETE BOOT UP ISSUE. THE GENERATOR AND THE WORKSTATION PRINTED CIRCUIT BOARDS WERE RESEATED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED. THIS EVENT MAY BE AN ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYSTEM FLUOROSCOPY BUTTON WOULD STICK DURING X-RAY AND AT TIMES WOULD NOT BOOT UP. 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 |