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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONARCH ENDOTOOL

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MONARCH ENDOTOOL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Electrolyte Imbalance (2196); Loss of consciousness (2418)
Event Date 01/04/2018
Event Type  Injury  
Event Description
Utilizing insulin algorithm software (monarch endotool) a pt was administered insulin 9 units as recommended by endotool. The pt was hypokalemic, potassium replacement was started simultaneously with initiation of insulin. The pt was transferred to the icu for dka management, he became unresponsive and coded due to an unstable cardiac arrythmia. Post code the pt was found to have critically low potassium level which contributed to the code.
 
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Brand NameENDOTOOL
Type of DeviceENDOTOOL
Manufacturer (Section D)
MONARCH
MDR Report Key7395366
MDR Text Key104467800
Report NumberMW5076287
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 03/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/03/2018 Patient Sequence Number: 1
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