FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3860826
·
Received April 14, 2014
Report
- Report Number
- 1720753-2014-03237
- Event Type
- Malfunction
- Date Received
- April 14, 2014
- Date of Event
- March 25, 2014
- Report Date
- April 14, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE RTOS AND GIB PCB COIN BATTERIES WERE EVALUATED AND REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A COMMUNICATION FAILURE ERROR MESSAGE. THIS ERROR INTERMITTENTLY PREVENTED THE SYSTEM FROM COMPLETING THE BOOT PROCESS. THERE IS NO REPORT OF A PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227770 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |