FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1319337
·
Received February 23, 2009
Report
- Report Number
- 1720753-2008-28328
- Event Type
- Malfunction
- Date Received
- February 23, 2009
- Date of Event
- October 29, 2008
- Report Date
- November 20, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER. THE GE SVC REP TROUBLESHOT SYSTEM AND CHECKED BATTERIES UNDER LOAD. HE PERFORMED THE HV ARCH TEST AND FOUND NO ARCHS. HE FLUOROED THE SYSTEM FOR 15 MINUTES STRAIGHT AND COULDN'T DUPLICATE THE ERROR. THE SYSTEM OPERATES AS DESIGNED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM IS HAVING KV AND MA PROBLEMS.
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 |