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

Model Number MAC5500

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Injury (2348)

Event Date 02/28/2015

Event Type  malfunction  

Event Description

A pt's name was chosen in error from a list of ekgs needing to be completed after the 'correct' patient's name had been hand entered and the machine switched off and back on again (manually).Subsequently, the ekg with the incorrect pt's name on it uploaded to the actual pt's medical record although this ekg was not from the actual pt herself.This ekg was completed in the emergency department after the actual pt was already up on ccmu (critical care medical unit).The actual pt went up to ccmu at 2100 and this ekg was completed on patient in the emergency dept at 2120.Based on an (the) ekg uploaded to the actual patient's chart, the actual patient underwent cardiac cath.The ekg had the actual patient's name on it.The ekg that the catheterization was based on was found to be that of the incorrect patient chosen in error from the list of ekg's needing to be completed).Manufacturer is aware of the issue and was able to duplicate the problem at the company.No permanent fix at this time.Risk for harm still exists.This resulted in an adverse event of the wrong procedure that was performed on the wrong patient.Manufacturer cannot revert back to an older software version.

• Brand Name: MAC 5500 HD
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GE MEDICAL INFORMATION TECHNOLOGIES, INC.; 8200 w tower ave; milwaukee WI 53223
• MDR Report Key: 4722051
• MDR Text Key: 15320168
• Report Number: 4722051
• 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 a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: MAC5500
• 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
• Patient Age: 68 YR
• Patient Weight: 48