FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2153434
·
Received June 21, 2011
Report
- Report Number
- 1720753-2011-08384
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. TECHNICAL SUPPORT WAS PROVIDED TO THE CUSTOMER TO REPAIR THE POWER SUPPLY BY INCREASING THE PS1 VOLTAGE. THE SYSTEM WAS WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE SYSTEM LOCKED UP AND DISPLAYED A COMMUNICATION ERROR MESSAGE BETWEEN THE GENERATOR AND THE WORKSTATION. NO PATIENT 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 |