FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2090585
·
Received April 26, 2011
Report
- Report Number
- 1720753-2011-06539
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 26, 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
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE S-RAM MEMORY CARD ON THE TECHNIQUE PROCESSOR BOARD WAS REPLACED BUT THE PROBLEM PERSISTED SO THE NEW CARD WAS REMOVED. NO FURTHER REPAIR INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9600 SYSTEM DISPLAYED A NO BOOT UP ERROR AND WOULD NOT TURN ON. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |