FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1832383
·
Received September 3, 2010
Report
- Report Number
- 1720753-2010-02975
- Event Type
- Malfunction
- Date Received
- September 3, 2010
- Date of Event
- August 19, 2010
- Report Date
- September 8, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND REPLACED THE ISD BOARD. TESTED SYSTEM IN DIFFERENT OPERATING ROOM SUITES, AND SYSTEM BOOTS PROPERLY W/O ALARMING. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SYSTEM ALARMS WHEN PLUGGED IN AND WILL NOT BOOT, AND ARE ONLY ABLE TO USE THE SYSTEM IN ONE OPERATING ROOM, AND THE ALARM WOULD SOUND EVERYWHERE ELSE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |