FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2934159
·
Received January 3, 2013
Report
- Report Number
- 1720753-2013-00099
- Event Type
- Malfunction
- Date Received
- January 3, 2013
- Date of Event
- February 12, 2012
- Report Date
- January 3, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE 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 DISPLAYED AN INTERMITTENT INTERLOCK FAILURE ERROR MESSAGE. THIS ERROR MESSAGE WILL LIKELY CAUSE THE SYSTEM TO SHUT DOWN. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4152 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |