FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2241289
·
Received August 17, 2011
Report
- Report Number
- 1720753-2011-21085
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 8, 2011
- Report Date
- August 17, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- 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. PIN 32 ON PLUG 9PL1 WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE ON/OFF SWITCH WOULD NOT ENGAGE AND THAT THE SYSTEM WOULD NOT TURN ON. 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 |