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

Model Number	SCCS-1001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	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.The device was not returned.
Event or Problem Description
It was reported that sensica device had damaged pins.Biomed stated they will send the device in for quality check.
Event or Problem Description
It was reported that the sensica device had damaged pins.The biomed people stated they will send the device in for a quality check.
Additional Manufacturer Narrative
The reported event was confirmed.The root cause of the reported issue was due to isolated to a use-related.The pins on the load cell were bent/twisted.(evidence of a ring being turned too much or in the wrong direction).The load cell assembly was replaced.The servicing was performed as per the test procedure.The device functionating properly and was ready for use.The product would 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 when connecting the single patient use, sensica uo ring to the system stand, use a firm, clockwise twisting motion.Do not apply excessive force or torque to the ring or the system's ring interface when connecting the device to avoid damaging components." corrections: d10, h3.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 MONITOR
• Manufacturer (Section D): ADAPTEC MEDICAL DEVICES LLC 3014271001; 260 james jackson avenue; cary NC 27513
• MDR Report Key: 10194624
• Report Number: 1018233-2020-04071
• Device Sequence Number: 2404628
• Product Code: EXS
• UDI-Device Identifier: 00854003008002
• UDI-Public: (01)00854003008002
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 10/07/2020

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: 06/25/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 06/25/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1