FDA Adverse Event
Malfunction
Summary report: N
STENOSCOP
MDR report key: 2241278
·
Received August 17, 2011
Report
- Report Number
- 9617766-2011-10811
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- April 22, 2008
- Report Date
- August 17, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE AND NO ADDITIONAL SERVICE INFORMATION WAS PROVIDED. DURING A RETROSPECTIVE REVIEW THIS EVENT WAS DETERMINED TO BE REPORTABLE. IT WAS INCLUDED AS PART OF A (B)(4) REQUEST TO FDA ON (B)(4) 2011 ((B)(4)). FDA REQUESTED THIS EVENT TO BE REMOVED FROM THE (B)(4) REQUEST AND FILED VIA 3500A.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE LOSS OF SYNCHRONIZATION ON THE FLUOROSCOPY MONITOR. 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 |