FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1375922
·
Received February 25, 2009
Report
- Report Number
- 1720753-2009-01652
- Event Type
- Malfunction
- Date Received
- February 25, 2009
- Date of Event
- January 28, 2009
- Report Date
- February 23, 2009
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THE GE SERVICE REP REPLACED THE PS1 AND PERFORMED FUNCTIONAL CHECKS. THE SYSTEM IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE XRAY POWER (KVP) BEGAN FLUCTUATING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |