FDA Adverse Event
Malfunction
Summary report: N
8800
MDR report key: 2062137
·
Received April 6, 2011
Report
- Report Number
- 9617766-2011-00814
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- March 9, 2011
- Report Date
- April 6, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE BIOS SETTING WAS RECONFIGURED AND THE INTERFACE BOARD IN THE MONITOR CART WAS REFITTED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 8800 SYSTEM WOULD INTERMITTENTLY HAVE RING ARTIFACTS IN THE IMAGE AND THE SYSTEM WOULD NOT BOOT UP. NO PT 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 |