FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 4152374
·
Received October 3, 2014
Report
- Report Number
- 1720753-2014-08387
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Date of Event
- September 17, 2014
- Report Date
- October 3, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE PS1 WAS EVALUATED AND RESEATED. THE VOLTAGE ON PS1 POWER SUPPLY WAS READJUSTED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED INTERMITTENT COMMUNICATION FAILED ERROR MESSAGES. THIS ERROR RESULTS IN X-RAYS BEING DISABLED. THIS RESULTED IN A LOSS OF IMAGING FUNCTIONALITY. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 617704 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |