MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SENSICA UO MONITOR ICU

Model Number SCCS1002

Device Problem Operating System Becomes Nonfunctional (2996)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that there were four monitors of sensica device that experienced screen freezing issues.It was suspected that there were liquid droplets on the screen in all four cases.The screens were frozen and did not respond to touch.The units were fixed by allowing the battery to drain and the system to restart.

Event Description

It was reported that there were four monitors of sensica device that experienced screen freezing issues.It was suspected that there were liquid droplets on the screen in all four cases.The screens were frozen and did not respond to touch.The units were fixed by allowing the battery to drain and the system to restart.Per email response received on 27dec2021, it was stated that the device number was still unknown, and a patient was involved but remained unaffected by the issue.The sensica device was repaired onsite.The issue was resolved by restarting the monitor.

Manufacturer Narrative

The reported issue was inconclusive as the device was not returned.The root cause of the reported issue could not be determined.A potential root cause of the reported issue could be projective capacitive touch screen failure due to water inclusion.However, this cannot be confirmed.It was unknown if the device met specifications and whether the device was influenced by the reported failure.The device was in use by a patient.The serial number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "ifu for properly charging the device: when first using the sensica uo system, the internal back-up battery may require charging.Plug the system into a medical grade wall supply using the power cord provided, and allow a 20 hours to charge battery.To avoid battery drainage over time, is recommended to keep the system plugged into the wall during use whenever possible.The battery will recharge when the system is plugged into a wall supply.Cautions: during system start up and in general practice, plug the sensica uo system into a wall power supply whenever possible.After using the system on batter back-up, plug it back into the wall power supply recharging and to avoid system shut down due to a drained battery." the device was not returned.

• Brand Name: SENSICA UO MONITOR ICU
• Type of Device: SENSICA UO MONITOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13125910
• MDR Text Key: 285045197
• Report Number: 1018233-2021-08632
• Device Sequence Number: 1
• Product Code: EXS
• UDI-Device Identifier: 00801741215773
• UDI-Public: 00801741215773
• 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: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCCS1002
• Device Catalogue Number: SCCS1002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other