FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2152931
·
Received June 17, 2011
Report
- Report Number
- 1720753-2011-08267
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- June 2, 2011
- Report Date
- June 17, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION AND REPLACED THE INTERCONNECT CABLE ASSEMBLY. 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 HAD A PROBLEM WITH THE CONNECTION BETWEEN THE MONITOR CART AND THE C-ARM THAT CAUSED VIDEO ISSUES OUTSIDE OF A CASE. NO PATIENT 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 |