FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2961638
·
Received February 11, 2013
Report
- Report Number
- 1720753-2013-01646
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 4, 2013
- Report Date
- February 11, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SNUBBER AND CHARGING CIRCUIT DRIVER BOARDS WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WAS DISPLAYING LOW MA ERROR MESSAGES. HOWEVER, THE FIELD ENGINEER'S INVESTIGATION DETERMINED THAT X-RAY WAS NOT FUNCTIONING AND THE SYSTEM WAS ALSO DISPLAYING A PERMANENT PRECHARGE ERROR MESSAGE. THE SYSTEM WAS INOPERABLE. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59654 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |