FDA Adverse Event Malfunction Summary report: N

9800

MDR report key: 2182744 · Received July 11, 2011

Report

Report Number
1720753-2011-08893
Event Type
Malfunction
Date Received
July 11, 2011
Date of Event
June 27, 2011
Report Date
July 11, 2011
Manufacturer
GE OEC MEDICAL SYSTEMS (SLC)
Product Code
JAA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
GM
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE AND NO ADD'L SVC INFO WAS PROVIDED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE SYSTEM'S CINE FUNCTION WOULD NOT WORK. NO PT INJURY WAS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9800

Patients

Seq Age Sex Outcome Treatment
1