FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2153520
·
Received June 21, 2011
Report
- Report Number
- 1720753-2011-08367
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- May 31, 2011
- Report Date
- June 21, 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. THE SOFTWARE AND CONFIGURATION DATA WERE RELOADED. THE CINE DRIVES WERE REFORMATTED, THE IMAGES WERE ANNOTATED AND THE STORAGE WAS VERIFIED. THE HARD DRIVE IN THE WORKSTATION WAS 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 CINE RUNS DID NOT PLAY BACK PROPERLY AND THAT THE SYSTEM WOULD LOCK 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 |