FDA Adverse Event
Malfunction
Summary report: N
2600
MDR report key: 1921659
·
Received December 7, 2010
Report
- Report Number
- 1720753-2010-04520
- Event Type
- Malfunction
- Date Received
- December 7, 2010
- Date of Event
- November 18, 2010
- Report Date
- December 7, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER SERVICE REPRESENTATIVE CHECKED TABLE MOVEMENT MICRO SWITCHES. COULD NOT DUPLICATE FAILURE. SYSTEM WAS RETURNED TO CUSTOMER. THE SYSTEM FUNCTIONS AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED GETTING ERRORS, UNABLE TO MAKE X-RAY AND UNABLE TO POWER UP. NO PT INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |