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	Insufficient Information (4580)
Date of Event	03/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
1 of 3 reports (same patient, same event, different products).Other mfg report numbers: 3013886523-2024-00124 3006697299-2024-00048 a facility reported a patient had a cerelink sensor placed (id (b)(4)).The sensor was used with cerelink monitor (id (b)(4)) and cerelink cable (id (b)(4)).The problems started immediately with a decompressed patient: at a certain point the monitor started giving an error and the value of the pressure disappeared.The monitoring was delayed more than 30 minutes due to product malfunction.The patient was stable and medical staff stopped monitoring.
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
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h11 the cerelink monitor was returned for evaluation: dhr - the batch record was reviewed for any anomalies or ncs related to the finished device, and none were identified.Failure analysis - the device clk2139082 received only with dc power supply.The costumer didn't send icp cable sensor.The device will be tested with our test icp test cable.The device is working properly and no fault was found.This device has the latest revision of the digital board, analog board and touchscreen.The safety and functional test must be performed.Root cause - the device was tested 3 days connected with our test equipment.The monitor is working properly, and no fault was found.A potential cause of the reported failure may have been related to the security of the connections to the monitor.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Investigation update: failure analysis - the report of error 1019 (output channel error) with disappearing values has not been confirmed.

• 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: 19193389
• Report Number: 3014334038-2024-00087
• Device Sequence Number: 12852321
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/27/2025

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 02/06/2025
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 01/28/2025; 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2021
• 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
• Patient Sex: Unknown