FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1872106
·
Received October 14, 2010
Report
- Report Number
- 1720753-2010-03579
- Event Type
- Malfunction
- Date Received
- October 14, 2010
- Date of Event
- October 4, 2010
- Report Date
- October 14, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REP EVALUATED THE SYSTEM AND FOUND THAT THE VOLTAGE OUTPUT AT ISOLATION TRANSFORMER WAS TOO HIGH, 126VAC IN CERTAIN OUTLETS IN THE OPERATING ROOM, CAUSING THE ALARM. RETAPPED ISOLATION TRANSFORMER AND NOW HAVE AN OUTPUT OF 118VAC. TESTED SYSTEM OPERATION WITHOUT ANY FURTHER PROBLEMS, SYSTEM IS OPERATING AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED THE SYSTEM DID NOT POWER UP, THEN DID POWER UP, BUT WOULD NOT FLUORO, IT JUST BEEPS CONTINUOUSLY. 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 |