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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. DATA INTERFACE UNIT CENTRAL STATION

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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. DATA INTERFACE UNIT CENTRAL STATION Back to Search Results
Model Number MAS700
Device Problems Device Alarm System (1012); Loss of Power (1475)
Patient Problem No Information (3190)
Event Date 05/20/2018
Event Type  Malfunction  
Event Description

Around 13:19; monitor was giving 55 min warning that it will shut off if we don't restart monitor. Monitors shut off, but it came back right away. Per site reporter: manufacturer is investigating.

 
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Brand NameDATA INTERFACE UNIT
Type of DeviceCENTRAL STATION
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8200 west tower avenue
milwaukee WI 53223
MDR Report Key7609827
MDR Text Key111388343
Report Number7609827
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 05/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/18/2018
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberMAS700
OTHER Device ID Number36774
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/22/2018
Device Age6 mo
Event Location Hospital
Date Report TO Manufacturer05/22/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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