FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2152238
·
Received June 23, 2011
Report
- Report Number
- 1720753-2011-08459
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 23, 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 ON SITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE GENERATOR INTERFACE BOARD, THE FLUORO FUNCTIONS BOARD AND THE SYSTEM INTERFACE WERE REPLACED. THE BACKPLANE AND THE PS1 POWER SUPPLY 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 HAD A COMMUNICATION FAILURE ERROR MESSAGE OUTSIDE OF A CASE. 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 |