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

Catalog Number	826820
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
1 of 3 complaints (same patient, same event, different products).Other mfg report numbers: 3006697299-2024-00102 3013886523-2024-00202.A facility reported a patient had a decompressive craniectomy and was rolled to relieve pressure areas.No disconnection of cables or monitor alarms.A short time after the monitor message was "sensor or extension cable failure".Medical staff was unable to resolve as screen would not change, and was unable to monitor icps.All trouble shooting carried out correctly, as the sales representative was there personally to troubleshoot.New monitor and cables connected which displayed the same screen.Sensor surgically removed from patient.
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.
Additional Manufacturer Narrative
The cerelink monitor was returned for evaluation: dhr - the batch record was reviewed for any anomalies or ncs, during production, related to the finished device.None were identified related to this report.Failure analysis - we checked the device with our test icp cable, and the monitor is working properly.The battery is more than 3 years old so must be replaced.The shipping carton is missing and will be added.The battery has been replaced.The full functional test and safety test according to manufacturer's specification has been performed.Root cause - the problem indicated by the customer has been not confirmed.The device (b)(6) received without icp extension and without power supply.We checked the device with our test icp cable, and the monitor is working properly.
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 02048
• Manufacturer (Section G): INTEGRA LIFESCIENCES MANSFIELD; 11 cabot boulevard; mansfield MA 02048
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 19721991
• Report Number: 3014334038-2024-00147
• Device Sequence Number: 8190517
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown