FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2092809
·
Received May 5, 2011
Report
- Report Number
- 9617766-2011-01000
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Date of Event
- April 18, 2011
- Report Date
- May 5, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE COLLIMATOR CONNECTIONS WERE CLEANED, THE KEYBOARD PLATE AND THE 62 PIN AMPERE PLUG WERE REPLACED. 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 THE SYSTEM DISPLAYED A CIRCULAR SHADOW ON BOTH SCREENS, THE CONNECTOR SOCKET FOR THE CRADLE WAS BROKEN AND THE KEYBOARD WAS FAULTY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STENOSCOP | FLUOROSCOPIC X-RAY | JAA | GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE) | STENOSCOP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |