FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 1981527
·
Received January 31, 2011
Report
- Report Number
- 1720753-2011-00752
- Event Type
- Malfunction
- Date Received
- January 31, 2011
- Date of Event
- January 5, 2011
- Report Date
- January 31, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE PS1 POWER SUPPLY WAS REPLACED DURING THE SERVICE CALL. THE FACILITY POWER WAS MEASURED AND FOUND TO FLUCTUATE. THE HOSPITAL ELECTRICIAN IS TO REPAIR THE LINE POWER ISSUE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 2800 SYSTEM WOULD NOT START UP AND THERE WAS AN INTERMITTENT TABLE COMMUNICATIONS ERROR. 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 |