FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2152542
·
Received June 22, 2011
Report
- Report Number
- 1720753-2011-08409
- Event Type
- Malfunction
- Date Received
- June 22, 2011
- Date of Event
- June 14, 2011
- Report Date
- June 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP CONDUCTED AN ONSITE INVESTIGATION. THE REPORTED PROBLEM COULD NOT BE DUPLICATED. THE CONTACTS ON THE POWER SUPPLY CONNECTIONS WERE CLEANED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM LOCKED UP. 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 |