FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2030583
·
Received March 9, 2011
Report
- Report Number
- 9617766-2011-00567
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- February 10, 2011
- Report Date
- March 9, 2011
- Manufacturer
- GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD. (GE PRIVATE)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND FOUND THE DIGITAL ACQUISITION COMPUTER OR ITS CPU NEED TO BE REPLACED. NO PARTS ARE AVAILABLE FOR THIS SYSTEM DUE TO ITS AGE. NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WILL NOT BOOT UP. NO PATIENT 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 |