FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2152709
·
Received June 24, 2011
Report
- Report Number
- 1720753-2011-08517
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- June 20, 2011
- Report Date
- June 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE HIGH VOLTAGE POWER SUPPLY TO THE INTENSIFIER NEEDS TO BE REPAIRED AND PARTS HAVE BEEN ORDERED. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A PROCEDURE, THE SYSTEM SHUT DOWN UNCOMMANDED, WOULD BOOT UP, AND THE HIGH VOLTAGE POWER SUPPLY TO THE INTENSIFIER WAS UNSTABLE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |