FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2212806
·
Received July 20, 2011
Report
- Report Number
- 9617766-2011-01147
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- May 22, 2011
- Report Date
- June 1, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE BOARDS ON THE MOTHERBOARD AND THE CONNECTORS WERE RESEATED. 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 WOULD NOT LOAD UPON BOOT 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 |