FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2202573
·
Received August 5, 2011
Report
- Report Number
- 9680959-2011-01682
- Event Type
- Malfunction
- Date Received
- August 5, 2011
- Date of Event
- July 27, 2011
- Report Date
- August 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HAND SWITCH, THE POWER CORD, AND THE INTERCONNECT CABLE WERE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S HAND SWITCH WOULD NOT WORK AND THE SYSTEM SHUT DOWN UNCOMMANDED. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7700 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |