FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2152690
·
Received June 24, 2011
Report
- Report Number
- 1720753-2011-08520
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- June 8, 2011
- Report Date
- June 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE CART CABLE CONNECTOR AND THE IMAGE CHAIN BOARD CONNECTOR CONTACTS WERE ENHANCED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT INTERMITTENTLY THE SYSTEM WOULD NOT CAPTURE FLUOROSCOPIC X-RAYS AND REQUIRED SEVERAL POWER ON AND POWER OFF EVENTS TO RECOVER. 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 |