FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 1861153
·
Received October 4, 2010
Report
- Report Number
- 1720753-2010-03362
- Event Type
- Malfunction
- Date Received
- October 4, 2010
- Date of Event
- September 15, 2010
- Report Date
- October 4, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE ARM CONTROL SWITCH AND THE EXTENSION BOARD. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE ARM IS STUCK AND CANNOT BE RELEASED AND THERE IS A PROBLEM WITH THE HAND RELEASE ON THE RIGHT FOOTBOARD. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |