FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3960273
·
Received June 24, 2014
Report
- Report Number
- 1720753-2014-05381
- Event Type
- Malfunction
- Date Received
- June 24, 2014
- Date of Event
- May 27, 2014
- Report Date
- June 23, 2014
- Manufacturer
- GE OCE MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE VOLTAGE ON PS1 WAS EVALUATED AND 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 DIN A LOSS OF IMAGING FUNCTIONALITY. T HERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367385 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OCE MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |