FDA Adverse Event
Malfunction
Summary report: N
GE OEC APIX TABLE
MDR report key: 1232500
·
Received November 13, 2008
Report
- Report Number
- 1720753-2008-28006
- Event Type
- Malfunction
- Date Received
- November 13, 2008
- Date of Event
- October 23, 2008
- Report Date
- November 10, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE HEALTHCARE EVALUATED THE SYSTEM AND DETERMINED THE MOTION CONTROLLER CPU NEEDS TO BE REPLACED. CUSTOMER HAS NOT YET DECIDED ON REPAIRS. THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER.
Description of Event or Problem · 1
CUSTOMER REPORTED THE TABLE STOPPED WORKING DURING A CASE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC APIX TABLE | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | APIX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |