FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 5142306
·
Received October 10, 2015
Report
- Report Number
- 1720753-2015-04170
- Event Type
- Malfunction
- Date Received
- October 10, 2015
- Date of Event
- September 23, 2015
- Report Date
- March 22, 2016
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- OWB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE 5 VDC POWER SUPPLY 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 FUNCTIONALITY. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 673953 | 9900 | FLUOROSCOPIC X-RAY | OWB | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |