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U.S. Department of Health and Human Services

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

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GENERAL ELECTRIC HEALTHCARE TECHNOLOGY MAC 5500 ELECTROCARDIOGRAPH Back to Search Results
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.

 
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Brand NameMAC 5500
Type of DeviceELECTROCARDIOGRAPH
Manufacturer (Section D)
GENERAL ELECTRIC HEALTHCARE TECHNOLOGY
9900 w. innovation dr.
wauwatosa WI 53226
MDR Report Key6085267
MDR Text Key59390421
Report Number6085267
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 11/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/08/2016
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
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 FDA11/02/2016
Device Age9 yr
Event Location Hospital
Date Report TO Manufacturer11/02/2016
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
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