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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 IV 1.8.0 -1.10.1
Device Problem Application Program Problem: Dose Calculation Error (1189)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2020
Event Type  malfunction  
Manufacturer Narrative
Method 1 was removed from the most-recently cleared version of endotool iv. Monarch has notified all customers whose parameters include the use of method 1 of this issue, reminding them to always have the basal transition dosing recommendation verified by a physician prior to administering the dose. A tip card has also been provided with this information. To eliminate the risk of this issue recurring, monarch is requesting that customers upgrade to the newest software version of the endotool iv (b)(4) application, which only uses method 0 to calculate tdd. Customers who cannot upgrade soon will be offered a parameter adjustment, switching from use of method 1 to method 0 in their application.
 
Event Description
Monarch medical technologies has received complaints from customers that the basal transition dosing recommendation calculated by endotool iv 1. 8. 0 - 1. 10. 1 applications was higher than expected. None of the reported cases resulted in patient harm, as the bedside clinician was able to easily recognize the dose as being too high. Investigation concluded that one of the methods used for the tdd (total daily dose) calculation can result in an elevated basal transition dosing recommendation. The reporting customers each had "method 1" in use when they received elevated basal transition dosing recommendations from the application. Due to recurrence of this incident, we initiated an internal review of cases and found that the tdd method 1 was the cause of high transition recommendation in the prior cases, resulting in monarch the filing a 30 day mdr for this issue. This has been corrected in the next version of the software. Customers have been instructed to select a different tdd method in the affected versions of the software until they are able to upgrade to the new version.
 
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Brand NameENDOTOOL IV
Type of DeviceENDOTOOL IV
Manufacturer (Section D)
MONARCH MEDICAL TECHNOLOGIES
4400 stuart andrew blvd.
suite n
charlotte, nc
Manufacturer (Section G)
MONARCH MEDICAL TECHNOLOGIES
4400 stuart andrew blvd.
suite n
charlotte, nc
Manufacturer Contact
brian johnson
4400 stuart andrew blvd.
suite n.
charlotte, nc 
5249660
MDR Report Key9980931
MDR Text Key196676826
Report Number3009864844-2020-90002
Device Sequence Number1
Product Code NDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K053137
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIV 1.8.0 -1.10.1
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 Received03/04/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/10/2016
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: 04/21/2020 Patient Sequence Number: 1
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