FDA Adverse Event
Malfunction
Summary report: N
2600
MDR report key: 1014297
·
Received March 12, 2008
Report
- Report Number
- 1720753-2008-17940
- Event Type
- Malfunction
- Date Received
- March 12, 2008
- Date of Event
- March 3, 2008
- Report Date
- March 11, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN INVESTIGATION. BASED ON INFORMATION PROVIDED, THE FOLLOWING COMPONENTS HAVE BEEN REQUESTED. BATTERY PACK AND X-RAY TUBE. IT IS BELIEVED THAT ONCE THE IDENTIFIED COMPONENTS ARE REPLACED, THE REPORTED ISSUE WILL BE ADDRESSED. IF ANY ADDITIONAL INFORMATION IS RECEIVED THAT INDICATES OTHERWISE, A FOLLOWUP REPORT WILL BE SUBMITTED AS REQUIRED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HEAT SENSOR ON THE 2600 SYSTEM IS BLOCKING THE EXPOSURE. IT WAS NOTED THAT THE SYSTEM REQUIRES A NEW TUBE AND BATTERY. THERE WAS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 2600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |