FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2072459
·
Received April 8, 2011
Report
- Report Number
- 1720753-2011-03501
- Event Type
- Malfunction
- Date Received
- April 8, 2011
- Date of Event
- March 31, 2011
- Report Date
- April 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE MALFUNCTION COULD NOT BE DUPLICATED. THE BREAKER WAS INSPECTED AND THE CUT OFF SWITCH WAS REPLACED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 2800 SYSTEM HAD A PROBLEM WITH THE CUT OFF SWITCH. 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 |