FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 5240986
·
Received November 20, 2015
Report
- Report Number
- 1720753-2015-04716
- Event Type
- Malfunction
- Date Received
- November 20, 2015
- Date of Event
- November 4, 2015
- Report Date
- November 20, 2015
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- OWB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HARD DISK DRIVE AND USB HUB WERE EVALUATED AND REPLACED. THE SYSTEM SOFTWARE AND CALIBRATIONS WERE ALSO RELOADED. 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 THE SYSTEM INTERMITTENTLY FAILED TO BOOT AND EXHIBITED INTERMITTENT SYSTEM FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 770434 | 9900 | FLUOROSCOPIC X-RAY | OWB | GE OEC MEDICAL SYSTEMS (SLC) | 9900 | E9-0425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |