FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 5233816
·
Received November 18, 2015
Report
- Report Number
- 1720753-2015-04662
- Event Type
- Malfunction
- Date Received
- November 18, 2015
- Date of Event
- October 29, 2015
- Report Date
- November 18, 2015
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- OWB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE POWER MOTOR RELAY PCB WAS 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 THE SYSTEM DISPLAYED AN ERROR, FAILED TO BOOT AND EXHIBITED A NON-RECOVERABLE LOSS OF 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 |
|---|---|---|---|---|---|---|---|
| 762862 | 9900 | FLUOROSCOPIC X-RAY | OWB | GE OEC MEDICAL SYSTEMS (SLC) | 9900 | E2-0239 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |