FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1961157
·
Received January 11, 2011
Report
- Report Number
- 1720753-2011-00164
- Event Type
- Malfunction
- Date Received
- January 11, 2011
- Date of Event
- December 1, 2010
- Report Date
- January 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE PS1 AND PS2 POWER SUPPLIES WERE RESEATED AND THE 5 VOLT POWER SUPPLY ADJUSTED DURING THE SERVICE CALL.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM LOCKED UP WITH A COMMUNICATION FAILURE ERROR MESSAGE. 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 |