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

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 issue was confirmed.The root cause of the reported issue was caused by a faulty pcb that intermittently stops providing adequate power (5 volts) to run usb connections.The pcb would not provide a constant 5 volts to the usb port.The pcb is found to have an intermittent power issue when trying to provide 5v for usb port.The pcb assembly was replaced.Servicing of the unit was performed per test procedure.The device functions properly and is 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: "to attach the ring to the sensica uo system stand, turn the ring upside down and use a clockwise motion to twist and "lock" the ring onto the ring interface.Do not apply excessive force or torque to the ring or the system's ring interface when connecting the device to avoid damaging components.Do not turn the ring counterclockwise when attaching it.".

Event Description

It was reported that the sensica device had an error 0,6,1,0.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA UO MONITOR ICU
• 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: 11596260
• MDR Text Key: 248834921
• Report Number: 1018233-2021-80028
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• 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: 03/12/2021
• 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