FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2092484
·
Received May 2, 2011
Report
- Report Number
- 9617766-2011-00979
- Event Type
- Malfunction
- Date Received
- May 2, 2011
- Date of Event
- April 12, 2011
- Report Date
- May 2, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE U36 WAS SEATED INTO ITS SOCKET AND THE VOLTAGE WAS VERIFIED AND ADJUSTED TO THE FLUORO FUNCTIONS BOARD AND THE PRINTED CIRCUIT BOARD. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND WAS PUT BACK INTO SERVICE.
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 | 8800 | FLUOROSCOPIC X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) | 8800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |