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

Catalog Number SCCS1001

Device Problem Circuit Failure (1089)

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

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed.The root cause of the reported issue was due to a faulty printed circuit board that intermittently stops providing the adequate power (5 volts) to run the usb connections.The printed circuit board would not provide a constant 5 volts to the usb port.The printed circuit board was found to have an intermittent power issue when trying to provide 5 volts for usb port.The printed circuit board assembly was replaced.The load cell pin was bent and damaged causing the system not to the detect ring during the new session setup.The load cell assembly was replaced.The service was performed on the device as per the test procedure.The device was functioning properly and ready for use.It was unknown whether the unit was being used for the treatment at the time of the reported event.The product did not meet the specifications, and was influenced by the reported failure.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 ifu currently instructs the user on the proper method to use this device to avoid undue injury to the patient and damage to the product.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 the sensica device was not working properly.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA UO MONITORICU
• 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: 11615877
• MDR Text Key: 243861607
• Report Number: 1018233-2021-80029
• 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: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• 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: 09/14/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1