FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2040383
·
Received February 15, 2011
Report
- Report Number
- 1720753-2011-02244
- Event Type
- Malfunction
- Date Received
- February 15, 2011
- Date of Event
- February 25, 2011
- Report Date
- March 15, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE REP CONDUCTED AN ONSITE INVESTIGATION. THE GENERATOR BATTERY AND CROSS ARM BRAKE ASSEMBLY WERE REPLACED. THE SYSTEM WAS TESTED AND IS NOW OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9600 SYSTEM WOULD NOT BOOT UP. NO PT 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 |