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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES CIC PRO DETECTOR AND ALARM, ARRHYTHMIA

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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES CIC PRO DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number MP100D
Device Problem Thermal Decomposition of Device (1071)
Patient Problem Insufficient Information (4580)
Event Date 05/17/2021
Event Type  Malfunction  
Event Description

Power supply in the ge all in one monitor burnt out, second time in about 1 year. There is another like item that is happen to in the past as well but did not think much of it until now that it happened again on another monitor. Manufacturer response for central station, ge (per site reporter). The first time this happened they came out and replace the power supply and that was it. Since then we have been replacing it ourselves.

 
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Brand NameCIC PRO
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
8200 west tower ave
milwaukee WI 53223
MDR Report Key11884647
MDR Text Key252664365
Report Number11884647
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation BIOMEDICAL ENGINEER
Type of Report Initial
Report Date 05/21/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/26/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberMP100D
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/21/2021
Device Age4 yr
Event Location Hospital
Date Report TO Manufacturer05/26/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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