FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 4180234
·
Received October 15, 2014
Report
- Report Number
- 1720753-2014-08591
- Event Type
- Malfunction
- Date Received
- October 15, 2014
- Date of Event
- September 24, 2014
- Report Date
- October 14, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE UPS WAS EVALUATED AN 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 A UPS (UNINTERRUPTIBLE POWER SUPPLY) FAILURE ERROR MESSAGE INSTRUCTING USER TO RE-BOOT THE SYSTEM. SYSTEM FUNCTIONALITY WAS RECOVERABLE. THIS COULD CAUSE PROCEDURAL DELAYS. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 653649 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |