FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2160361
·
Received June 20, 2011
Report
- Report Number
- 1720753-2011-08312
- Event Type
- Malfunction
- Date Received
- June 20, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 20, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SOFTWARE WAS RELOADED. THE UPS BATTERIES NEED TO BE REPLACED AND THIS WILL BE DONE BY THE CUSTOMER. IT IS EXPECTED THAT REPLACEMENT OF THIS PART WILL RESTORE THE SYSTEM TO ITS INTENDED USE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. NO PT 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 |