MAUDE Adverse Event Report: GENERAL ELECTRIC HEALTHCARE TECHNOLOGY MAC 5500 ELECTROCARDIOGRAPH

Model Number MAC 5500

Device Problem Programming Issue (3014)

Patient Problem Left Ventricular Dysfunction (1947)

Event Date 08/30/2016

Event Type  Malfunction  

Event Description

Our general electric mac 5500 ecg machine had its voltage gain changed from 10mm/mv, its default setting, to 5mm/mv. This change went unnoticed through printing. Having the printout of the ecg at 5mm/mv masked an acute stemi. This resulted in a delay of care. Cardiology was consulted and noted that this patient experienced a decrease in left ventricular function, which may have been avoided with sooner cardiac intervention. Upon further inspection of the ecg unit we recognized that settings can be changed relatively easily. Simply pressing the f4 key, for example, prompts the user to select the voltage gain they want to proceed at. This creates a problem when the ec nurse doesn't know what the default settings of the machine are and incorrectly selects the wrong setting. The incorrect setting will remain in place until it is either corrected by again pressing the f4 key and selecting the correct setting, or the machine is powered down and then booted back up. The default setting does not return when a new patient is started within the machine. When default settings have been changed and a user attempts to print an ecg form the unit will display a pop up asking the user to verify the ecg settings. This pop up again relies on the end user knowing what settings the machine should be at. After this occurred at our facility our emergency medicine physicians became cognizant of these errors and vigilant about ensuring the correct voltage gain was run. One physician informed us that since this event, he has caught three additional ecgs that were handed to him for interpretation that were run at the incorrect setting. In an effort to stop this from happening we wanted to create hard-set defaults that could only be changed by authorized personnel. We learned that this cannot be done with these machines. We think incorporating a password scheme into the software to prevent front line staff from changing default settings on the ecg machine would mitigate these risks. Per the hospital, lines of communication has been opened with the manufacturer. The manufacturer intends to share this feedback with their r and d engineering departments.

• Brand Name: MAC 5500
• Type of Device: ELECTROCARDIOGRAPH
• Manufacturer (Section D): GENERAL ELECTRIC HEALTHCARE TECHNOLOGY; 9900 w. innovation dr.; wauwatosa WI 53226
• MDR Report Key: 6085267
• MDR Text Key: 59390421
• Report Number: 6085267
• Device Sequence Number: 1
• Product Code: DPS
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/02/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/08/2016
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device MODEL Number: MAC 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 FDA: 11/02/2016
• Device Age: 9 yr
• Event Location: Hospital
• Date Report TO Manufacturer: 11/02/2016
• 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

Patient TREATMENT DATA

Date Received: 11/08/2016 Patient Sequence Number: 1