FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2153485
·
Received June 21, 2011
Report
- Report Number
- 9617766-2011-01272
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 21, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE BATTERIES WERE REPLACED IN THE FRAME AND IN THE MONOBLOCK BOARD, AND THE REAR LEFT HANDLE WAS REPLACED. 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 DISPLAYED A GENERATOR ERROR MESSAGE AND LOCKED UP. 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 | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |