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U.S. Department of Health and Human Services

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

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GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC. MAC 5500 HD ELECTROCARDIOGRAPH Back to Search Results
Model Number MAC5500HD
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 03/05/2015
Event Type  Malfunction  
Event Description

A call to biomed was placed on a ekg cart in the emergency department with a problem description that it printed out the wrong patient information. Another cart seems have pulled the wrong patient information. The cart was taken to the main biomed shop to be checked. Multiple technical users(biomed tech, clinical engineers, risk management, etc. ) were going over the procedure of selecting a patient from the order management system on the cart. A patient that did not have completed orders (the only one from the list) was selected. When the return key was pressed it picked another patient that had already been completed. A box saying that this patient has already been processed did not appear but instead a box asking if you want to proceed popped up with a different patient. In a busy environment even someone with much experience may not have caught this. After diagnostics were performed on this cart on this day we have only been able to duplicate the problem this one time. A service call was placed to ge and i was told they would be looking into this. I received a call today saying that the software engineers were able to reproduce this problem.

 
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Brand NameMAC 5500 HD
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
8200 w tower ave
milwaukee WI 53223
MDR Report Key4722047
MDR Text Key5745012
Report Number4722047
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 04/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator UNKNOWN
Device MODEL NumberMAC5500HD
Device Catalogue NumberN/A
Device LOT NumberN/A
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2015
Event Location Hospital
Date Report TO Manufacturer04/23/2015
Is this a Reprocessed and Reused Single-Use Device? No

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