FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 1973737
·
Received January 17, 2011
Report
- Report Number
- 1720753-2011-00318
- Event Type
- Malfunction
- Date Received
- January 17, 2011
- Date of Event
- December 21, 2010
- Report Date
- January 17, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE BATTERY PACKS. SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A PRE-CHARGE VOLTAGE ERROR AND A FILAMENT ERROR WOULD NOT BOOT UP. THE PRE-CHARGE VOLTAGE ERROR WOULD PREVENT THE SYSTEM FROM PRODUCING X-RAYS. 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 |