FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2171391
·
Received June 30, 2011
Report
- Report Number
- 1720753-2011-08682
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 23, 2011
- Report Date
- June 30, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION AND WAS UNABLE TO REPLICATE THE ISSUE; HOWEVER, THERE WAS AN ERROR REFERRING TO THE IRIS POTENTIOMETER. THE IRIS WAS RECALIBRATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S MONITORS BOOTED UP WITH NO ISSUES; HOWEVER, THE C-RAM INTERMITTENTLY WOULD NOT BOOT UP. 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 |