MAUDE Adverse Event Report: INTEGRA LIFESCIENCES MANSFIELD CERELINK ICP EXT CABLE; CERELINK - CABLES

Catalog Number	826845
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
2 of 4 reports.Other mfg report numbers: 3014334038-2024-00051, 3013886523-2024-00072, 3013886523-2024-00073.A facility reported a cerelink monitor displayed an error message (failure sensor and extension): "monitor and cables were exchanged and this issue reappeared.Medical staff switched it off and on again after 3 minutes.They changed the cables and then the monitor but nothing worked.They removed the patient's icp.The patient was in intensive care today.Integra account manager visited the hospital and she tested the monitor with the patient's catheter and a new catheter.Everything worked perfectly.She then connected the cerelink to the patient monitor.After a few minutes, the monitor displayed the error message with the 2 probes.Bedside monitor : spacelabs 91393 xprezzon.Integra account manager tested the monitor in the patient's room and then tried it in another room with the same monitor and a different scope, and the error also appeared.When the monitor was turned off each time and then on again, it started up again and then went into alarm again.This is not a regular occurrence.The test was carried out with the same monitor, the same cable and 2 different fibres with 2 different scopes.".
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
Additional information received: monitor clk2210502/ 166288, patient monitor cable: 826883 , no lot number engraved.Extension cable ref 826845 : (b)(4).Implantation area? parenchyma.Was the electrode of the extension cable appropriately fixed on the patient? yes.When error message appeared, which actions was in progress? no specific action, it was during the night.Was patient transported or in a mri? no.How was the monitoring performed? (other method? stop?) they stopped monitoring.Was another sensor used? no.How is the patient? patient is no more in the department.Patient is an adult.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The cerelink extension cable was returned for evaluation: dhr - no anomalies during the manufacture or packaging that could be associated with the complaint incident was observed.Failure analysis - visual inspection: blood like stain was detected so additional analysis in tullamore was unable to be completed.Root cause - per ifu error code 1019 relates to output channel error.Recommendation: allow the unit to reboot or force a reboot by holding down the power button.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Failure analysis and root cause - this error is most likely caused by a fault with the monitor analogue board.Note the analogue board is connected to the patient monitor by the patient monitor cable.The returned icp extension cable was connected to an engineering monitor and no error was displayed on the monitor.

• Brand Name: CERELINK ICP EXT CABLE
• Common Device Name: CERELINK - CABLES
• 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: 18874098
• Report Number: 3006697299-2024-00031
• Device Sequence Number: 7919515
• Product Code: GWM
• UDI-Device Identifier: 10381780520665
• UDI-Public: 10381780520665
• 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,Followup,Followup
• Report Date (Section B): 09/19/2025

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: 826845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/12/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 06/11/2025; 09/01/2025
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 05/02/2024; 06/24/2025; 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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