FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2040958
·
Received March 23, 2011
Report
- Report Number
- 9617766-2011-00674
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- February 22, 2011
- Report Date
- March 23, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND A CONNECTOR NEEDED TO BE REPLACED. THE CONNECTOR WAS PLACED ON ORDER. IT IS ANTICIPATED THAT AFTER THE CONNECTOR IS REPLACED, THE SYSTEM WILL OPERATE AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN ADJUSTING THE HEIGHT OF THE C DURING FLUORO, THE SYSTEM DISPLAYED A GENERATOR ERROR. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |