FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2100232
·
Received May 16, 2011
Report
- Report Number
- 1720753-2011-07337
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Date of Event
- May 6, 2011
- Report Date
- May 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP ORDERED A NEW TABLE GENERATOR INTERFACE BOARD. IT IS ANTICIPATED THAT REPLACEMENT OF THIS PART WILL RESTORE THE SYSTEM TO OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYS DISPLAYED A COMMUNICATION FAILURE ERROR MESSAGE AND THAT THE TABLE FAILED. NO PT 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 |