FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2102167
·
Received April 20, 2011
Report
- Report Number
- 1720753-2011-06385
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- April 6, 2011
- Report Date
- April 20, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE HANDLE WAS REPLACED, THE GENERAL PURPOSE OPERATING SYSTEM PCB AND ALL RELATED CONNECTORS WERE RESEATED. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM DISPLAYED AN ERROR MESSAGE AND THE TURN OVER LOCK WAS BROKEN. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |