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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MAC 5500 ELECTROCARDIOGRAPH

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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MAC 5500 ELECTROCARDIOGRAPH Back to Search Results
Model Number 5500
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problems Atrial Fibrillation (1729); Tachycardia (2095)
Event Date 05/15/2015
Event Type  Malfunction  
Event Description

The pt. Was in rapid arterial fibrillation, heartrate was between 150-160 bpm; attempted by the nurses to do an ecg but the machine did not work. It is saying "terminating connection". The machine was disconnected. Orders won't even load.

 
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Brand NameMAC 5500
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
9900 w. innovation drive
wauwatosa WI 53226
MDR Report Key5017609
MDR Text Key23536805
Report Number5017609
Device Sequence Number1
Product Code DPS
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 07/08/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator
Device MODEL Number5500
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/08/2015
Event Location Hospital
Date Report TO Manufacturer07/08/2015
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? No
Type of Device Usage

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