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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE MEDICAL INFORMATION TECHNOLOGIES, INC. MAC 5500 ELECTROCARDIOGRAPH

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GE MEDICAL INFORMATION TECHNOLOGIES, INC. MAC 5500 ELECTROCARDIOGRAPH Back to Search Results
Model Number MAC 5500
Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913)
Patient Problem Cardiac Arrest (1762)
Event Date 02/09/2016
Event Type  Malfunction  
Event Description

After the patient was successfully resuscitated, a stat ekg was ordered due to cardiac arrest. The ekg machine did not function and alerted unable to connect.

 
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Brand NameMAC 5500
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GE MEDICAL INFORMATION TECHNOLOGIES, INC.
465 pan american drive suite 11
el paso TX 79907
MDR Report Key5459878
MDR Text Key38979896
Report Number5459878
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 02/23/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/25/2016
Is This An Adverse Event Report? Yes
Device Operator
Device MODEL NumberMAC 5500
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/23/2016
Event Location Hospital
Date Report TO Manufacturer02/23/2016
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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