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

Model Number	SCCS-1001
Medical Device Problem Code	Computer Operating System Problem (2898)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the sensica device had a load cell issue.
Event or Problem Description
It was reported that the sensica device had a load cell issue.Per follow up on 28may2020, engineer (b)(6) stated the sensica unit is being returned to bd for repairs.
Additional Manufacturer Narrative
The reported issue was unconfirmed.The root cause of the reported issue could not be determined as the reported issue could not be reproduced.The device was working properly.The device went through field action, the following components were replaced/added per the latest revision of the bill of material for sensica icu,rev h base pcba, rev c sensica icu base pcba firmware, rev d sensica icu application software, rev a windows enterprise os, rev a power supply label.Product label, usb connection label, was replaced with the latest revision of the label (rev c) per the latest bill of material for sensica icu.Replaced pcba, rev h with firmware.Servicing of the unit was performed per test procedure.The device functioned properly and 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 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.Indications: the sensica uo system is an automated urine meter system for continuous monitoring of urine output (uo) and core body/bladder temperature (bt).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." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: SENSICA UO MONITOR ICU
• Common Device Name: SENSICA
• Manufacturer (Section D): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• MDR Report Key: 10095855
• Report Number: 1018233-2020-03473
• Device Sequence Number: 948021
• Product Code: EXS
• UDI-Device Identifier: 00854003008002
• UDI-Public: (01)00854003008002
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCCS-1001
• Device Catalogue Number: SCCS1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2020
• Initial Date Received by Manufacturer: 05/08/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 05/28/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1