FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2820526
·
Received November 2, 2012
Report
- Report Number
- 1720753-2012-09011
- Event Type
- Malfunction
- Date Received
- November 2, 2012
- Date of Event
- October 17, 2012
- Report Date
- November 2, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE IDENTIFIED OR DUPLICATED. THE SYSTEM WAS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY LOCKED-UP AND DISPLAYED A COMMUNICATION ERROR MESSAGE DURING A CASE. THE CASE WAS COMPLETED WITH AN ALTERNATE SYSTEM. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |