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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE HEALTHCARE CLINICAL INFORMATION CENTER; MEDICAL DEVICE DATA SYSTEM
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GE HEALTHCARE CLINICAL INFORMATION CENTER; MEDICAL DEVICE DATA SYSTEM Back to Search Results
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913); Missing Test Results (3267)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2015
Event Type  malfunction  
Event Description
Our telemetry system is comprised of six cics (clinical information center).They are connected to monitors which give our nursing staff the vital signs needed for that patient.Once a week a member of telemetry or biomed need to shake the mouse that is connected to the cic or the cic will freeze up or it will not give certain vital signs for some patients: the vital signs do not show up on the cic.We have contacted the manufacturer but they are unable to determine the cause or a solution to the problem other than shaking the mice.Other cic's at this facility without the telemetry application do not have this problem.
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manufacturer response for cic, clinical information center (per site reporter)
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they told us that they do not have a solution at this point.
 
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Brand Name
CLINICAL INFORMATION CENTER
Type of Device
MEDICAL DEVICE DATA SYSTEM
Manufacturer (Section D)
GE HEALTHCARE
9900 w. innovation dr.
wauwatosa WI 53226
MDR Report Key4959641
MDR Text Key6041081
Report Number4959641
Device Sequence Number1
Product Code DSI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 07/06/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/07/2015
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer08/03/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/07/2015
Patient Sequence Number1
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