FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2021604
·
Received February 21, 2011
Report
- Report Number
- 1720753-2011-01511
- Event Type
- Malfunction
- Date Received
- February 21, 2011
- Date of Event
- February 7, 2011
- Report Date
- February 21, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE 5 VOLT POWER SUPPLY WAS ADJUSTED DURING THE SERVICE CALL. THE SYSTEM WAS FOUND TO BE WORKING AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9600 SYSTEM WOULD NOT BOOT UP. 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 |