FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2210567
·
Received August 8, 2011
Report
- Report Number
- 1720753-2011-20823
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- May 27, 2011
- Report Date
- August 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE LEFT MONITOR WAS REPLACED. 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 EMITTED A BURNING ODOR. ADD'L INFO WAS RECEIVED THAT THE LEFT MONITOR WOULD NOT WORK. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |