FDA Adverse Event
Malfunction
Summary report: N
9600+
MDR report key: 1000868
·
Received February 21, 2008
Report
- Report Number
- 1720753-2008-16270
- Event Type
- Malfunction
- Date Received
- February 21, 2008
- Date of Event
- February 12, 2008
- Report Date
- February 20, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN INVESTIGATION. BASED ON INFO PROVIDED THE FOLLOWING COMPONENT HAS BEEN ORDERED. COLLIMATOR ASSEMBLY. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENT IS REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADDITIONAL INFO IS RECEIVED THAT INDICATES OTHERWISE, A F/U REPORT WILL BE SUBMITTED AS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9600+ SYSTEM PRESENTED A BAD IRIS POT ERROR DURING BOOT UP. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600+ | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9600+ | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |