FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1280272
·
Received January 7, 2009
Report
- Report Number
- 1720753-2008-26510
- Event Type
- Malfunction
- Date Received
- January 7, 2009
- Date of Event
- September 15, 2008
- Report Date
- October 2, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP VERIFIED A LOW MA ERROR IN LOG FILE BUT COULD NOT DUPLICATE THE PROBLEM. HE PERFORMED A HVSR CAL PROCEDURE AND ACQUIRED DUTY CYCLE DATA. HE TESTED THE SYSTEM AND FOUND IT TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THERE WAS A LOW MA ERROR CODE THAT DISPLAYED ON THE SYSTEM. NO PATIENT INJURY WAS REPORTED.
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 |