FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2092742
·
Received May 5, 2011
Report
- Report Number
- 1720753-2011-06943
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- April 18, 2011
- Report Date
- May 5, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION. THE SURGE SUPPRESSOR BOARD WAS REPLACED AND THE CONNECTORS WERE TIGHTENED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT BOOT UP. 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 |