FDA Adverse Event Malfunction Summary report: N

7700

MDR report key: 2072507 · Received April 8, 2011

Report

Report Number
9680959-2011-01034
Event Type
Malfunction
Date Received
April 8, 2011
Date of Event
November 18, 2011
Report Date
April 8, 2011
Manufacturer
GE OEC MEDICAL SYSTEMS GMBH
Product Code
JAA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
GP
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

NO CONCLUSION CAN BE DRAWN AS REPAIR INFO IS UNAVAILABLE. HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THAT THE 7700 SYSTEM HAD NO IMAGE DISPLAYED. NO PT INJURY WAS REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS GMBH 7700

Patients

Seq Age Sex Outcome Treatment
1