MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP MONITOR; ICP MONITOR-CERELINK

Catalog Number	826820
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
A facility reported a cerelink monitor id (b)(4) showed an error message (error code 1000) during a traumatic brain injury (tbi) monitoring in the intensive care unit (icu).The unit rebooted by itself and was working fine after the issue.Every time the monitor moved a little the same error appeared.No patient injury reported.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11.The cerelink monitor ((b)(6)) was returned for evaluation.Device history record (dhr) - the batch records were reviewed for any anomalies or report related to the finished device, and none were identified.Failure analysis - cerelink monitor requires rework to bring the unit to the current design state.Requires analog board replacement to correct the error code 1000.The rework performed includes the following: updating the digital board to correct the lcd on-state when the monitor is powered off and updating the lcd touch screen to the latest revision.Replaced the lithium coin battery.Replaced lithium monitor battery.Final functional testing and electrical safety testing performed.Testing completed and the monitor has passed all functional and electrical safety tests.Root cause analysis - the returned cerelink monitor required component upgrade to bring the unit to the current design state.The analog board was replaced to correct error code 1000.Final functional and electrical safety testing completed.
Event or Problem Description
N/a.

• Brand Name: CERELINK ICP MONITOR
• Common Device Name: ICP MONITOR-CERELINK
• Manufacturer (Section D): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; 11 cabot boulevard; mansfield MA
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19011936
• Report Number: 3014334038-2024-00064
• Device Sequence Number: 7981548
• Product Code: GWM
• UDI-Device Identifier: 10381780533788
• UDI-Public: 10381780533788
• Combination Product (Y/N): N
• PMA/510(K) Number: K183406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

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 Catalogue Number: 826820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/17/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown