FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2073714
·
Received April 13, 2011
Report
- Report Number
- 1720753-2011-03573
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Date of Event
- March 17, 2011
- Report Date
- April 13, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE POWER SUPPLY ASSEMBLY, THE MOTOR RELAY PRINTED CIRCUIT BOARD, AND THE LIFT COLUMN ASSEMBLY WERE REPLACED. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM C-ARM WOULD NOT MOVE UP OR DOWN. NO PT 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 |