FDA Adverse Event Malfunction Summary report: N

7700

MDR report key: 2030290 · Received March 7, 2011

Report

Report Number
9680959-2011-00670
Event Type
Malfunction
Date Received
March 7, 2011
Date of Event
July 24, 2008
Report Date
March 7, 2011
Manufacturer
GE OEC MEDICAL SYSTEMS GMBH
Product Code
JAA
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
EG
Reporter Occupation
OTHER

Narratives

Additional Manufacturer Narrative · 1

THE GE REP EVALUATED THE SYSTEM AND REPLACED A LOW VOLTAGE POWER SUPPLY PLUG. THE SYSTEM OPERATES AS INTENDED.

Description of Event or Problem · 1

THE CUSTOMER REPORTED THE SYSTEM WILL NOT POWER UP. 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