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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 SOFTWARE VERSIONS 1.8.5 AND HIGHER
Device Problem Application Program Problem: Dose Calculation Error (1189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
All affected customer sites have been notified of the software bug. A patch was created and validated for endotool iv versions 1. 8. 5 and higher. The affected customer sites are being upgraded.
 
Event Description
A software bug was discovered in endotool iv version 1. 10. This bug is in an area of the software that addresses persistently elevated glucose levels. Investigation and analysis of the bug has determined it is very unlikely to re-occur. In the very unlikely event it does re-occur, it could cause the software to incorrectly calculate an insulin dose recommendation. Investigation determined there has been only one occurence of the bug. The dose recommendation was correctly not accepted by the bedside caregiver and there was no associated patient harm. All affected customer sites have been notified of the software bug. A patch was created and validated for endotool iv versions 1. 8. 5 and higher. The affected customer sites are being upgraded.
 
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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 Key8649269
MDR Text Key146484051
Report Number3009864844-2019-00001
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 Other Health Care Professional
Remedial Action Repair
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIV SOFTWARE VERSIONS 1.8.5 AND HIGHER
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 Received05/02/2019
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
Removal/Correction Number3009864844-5/9/2019-001C

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