FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2102147
·
Received May 19, 2011
Report
- Report Number
- 1720753-2011-07476
- Event Type
- Malfunction
- Date Received
- May 19, 2011
- Date of Event
- May 7, 2011
- Report Date
- May 19, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SURGE SUPPRESSOR WAS REPLACED AND THE EMERGENCY STOP MECHANISM EVALUATED. A REPLACEMENT PART FOR THE EMERGENCY STOP SYSTEM WAS ORDERED FOR THE CUSTOMER TO INSTALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S SURGE SUPPRESSOR WAS RECEIVED BUT WOULD NOT WORK AND THE FAST STOP SWITCH WAS BROKEN. 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 |