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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONARCH MEDICAL TECHNOLOGIES ENDOTOOL IV

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MONARCH MEDICAL TECHNOLOGIES ENDOTOOL IV Back to Search Results
Model Number WEB IV SOFTWARE VERSION 1.8.6
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2017
Event Type  malfunction  
Manufacturer Narrative
To monarch medical's knowledge, the alleged complaint has not re-occurred.
 
Event Description
Endotool web iv version 1. 8. 6 support case created for customer inquiry regarding a hypoglycemic event and the software's recommended dose of recovery carbohydrates. The original investigation of this case was inconclusive. Customer was contacted for additional information and later advised the case would be closed and re-opened at their request. Additional case for endotool web iv version 1. 7 for a customer inquiry regarding a hypoglycemic event and the software's recommended dose for iv insulin. Retrospective review of these cases has resulted in a determination to now submit this mdr. In both cases, user error contributed to the hypoglycemic event. In the web iv version 1. 8. 6 case, the endotool-recommended carbohydrate treatment was not followed and the patient soon had a hypoglycemic reading. For the web iv version 1. 7 case, the user returned to the application within 5 minutes of the previous recommendation and entered a new blood glucose reading. According to endotool labeling and functionality this was too soon to get an accurate drip recommendation and the patient had a hypoglycemic event. For both cases there was no patient harm. Also in both cases, if the user would have followed guidance from the endotool web iv application the events could have been prevented. Users have been re-educated on proper use of the software. Although our findings now indicate that endotool did not malfunction in either case, monarch is developing additional user educational materials to mitigate these user errors.
 
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Brand NameENDOTOOL IV
Type of DeviceENDOTOOL IV
Manufacturer (Section D)
MONARCH MEDICAL TECHNOLOGIES
2137 south blvd.
suite 300
charlotte NC 28203
Manufacturer (Section G)
MONARCH MEDICAL TECHNOLOGIES
2137 south blvd
suite 300
charlotte NC 28203
Manufacturer Contact
bruce lisanti
2137 south blvd.
suite 300
charlotte, NC 28203
8553637475
MDR Report Key8742385
MDR Text Key213918818
Report Number3009864844-2019-00002
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132547
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model NumberWEB IV SOFTWARE VERSION 1.8.6
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2019 Patient Sequence Number: 1
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