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

Catalog Number	826820
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/31/2024
Type of Reportable Event	Serious Injury
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
1 of 3 reports (same patient, same event, different products).Other mfg report numbers: 3006697299-2024-00044 3013886523-2024-00122 a facility reported a patient had a cerelink sensor placed (id 826850).The sensor was used with cerelink monitor (id 826820) and cerelink cable (id 826845).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 patient was critical and the event led to a delay in measuring the intracranial pressure (icp).Therefore, medical staff retrieve the system.The patient died; however, the facility confirmed, the death is related to the patient's critical condition (polytrauma).
Additional Manufacturer Narrative
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 / root cause - the device (b)(6) 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 monitor was tested 3 days connected with our test equipment.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 functional test and safety test according to manufacturer's specification have been performed.
Additional Manufacturer Narrative
Investigation update.Failure analysis - the report of error 1019 (output channel error) with disappearing values has not been confirmed.
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: 19192951
• Report Number: 3014334038-2024-00083
• Device Sequence Number: 15571819
• 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?: No
• 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): Follow-Up
• 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: 01/27/2025; 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