FDA Adverse Event
Malfunction
Summary report: N
APIX TABLE
MDR report key: 1645580
·
Received March 12, 2010
Report
- Report Number
- 1720753-2010-00668
- Event Type
- Malfunction
- Date Received
- March 12, 2010
- Date of Event
- October 1, 2009
- Report Date
- March 9, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- KXJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THE CPU, CONTROL PANEL, AND BATTERY PACK NEEDED TO BE REPLACED. CUSTOMER HAS DECLINED REPAIRS.
Description of Event or Problem · 1
CUSTOMER REPORTED, THE TABLE WILL NOT MOVE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APIX TABLE | TABLE | KXJ | GE OEC MEDICAL SYSTEMS (SLC) | APIX TABLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |