FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3013171
·
Received March 1, 2013
Report
- Report Number
- 1720753-2013-03227
- Event Type
- Malfunction
- Date Received
- March 1, 2013
- Date of Event
- February 8, 2013
- Report Date
- March 1, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE ORBITAL MOTOR ASSEMBLY CLUTCH WAS IDENTIFIED AS BEING DEFECTIVE. THE REPAIR IS PENDING CUSTOMER APPROVAL OF THE QUOTE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED A MOTION DISABLED ERROR MESSAGE AND WAS UNABLE TO PERFORM MOTORIZED MOVEMENTS. THIS IS CRITICAL FOR THE TYPE OF IMAGING THE MOTORIZED C-ARM WAS DESIGNED FOR. THE SYSTEM WOULD BE EFFECTIVELY UNUSABLE. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 90504 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |