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

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.

• Brand Name: MAC 5500 HD
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.; 8200 w tower ave; milwaukee WI 53223
• MDR Report Key: 4722047
• MDR Text Key: 5745012
• Report Number: 4722047
• Device Sequence Number: 1
• Product Code: DPS
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: MAC5500HD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2015
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/21/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1