MAUDE Adverse Event Report: ADAPTEC MEDICAL DEVICES LLC 3014271001 SENSICA UO MONITOR ICU

Catalog Number SCCS1001

Device Problem Computer Software Problem (1112)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed however the cause was unknown.The root cause of the reported issue could be due to an error, 1.1 a critical template file that did not properly download during installation.It was found that during original installation of sw version 1.1 that a critical template file for the electronic health record (ehr) connectivity was not present.Version 1.1 was re-installed and made sure that the proper template file was downloaded correctly.Servicing of the unit was performed per test procedure.The device functioned properly and was ready for use.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "the sensica uo system for icu is designed for precise measurement using the disposable, sensica uo ring, which is part of the sensica uo patient ring kit.Each time the system is used with a new patient, a new sensica uo ring must be connected to the senica uo stand.The system software is designed to calibrate each time a new ring is attached to ensure accurate calculations of urine output volume.".

Event Description

It was reported that there was an electronic health records (ehr) setting issue with the sensica device.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA UO MONITOR
• Manufacturer (Section D): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• Manufacturer (Section G): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 11646230
• MDR Text Key: 244842556
• Report Number: 1018233-2021-80030
• Device Sequence Number: 1
• Product Code: EXS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SCCS1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1