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

Catalog Number	826820
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
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
It was reported that the cerelink icp monitor (826820) "was on an iv pole and a bag of solution dripped into the power strip that it was plugged into and an electrical situation happened where sparks were coming out".Staff plugged in a new cable, and believed the device worked fine but would like device evaluated to ensure it is working to specification.No patient injury, death or surgical delay was reported.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h11.Corrected field: h6 (impact code 1).Additional information: b5.B5: it was subsequently reported that the device was not in use on a patient at the time of the event; thus, there was no patient impact or delay in procedure.
Event or Problem Description
See h11.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The cerelink icp monitor (b)(6) was returned for evaluation.Based on the device history record (dhr) review conducted, there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the power supply was found to be burned out as a result of the spillage.The following repairs were made: disassembled console and inspected, reassembled console upon inspection and completed preventive maintenance (pm) checks and tests.All pm checks and tests passed with no issue.The burned out power supply was replaced.The complaint could be verified through failure analysis.Root cause - the complaint was confirmed in the complaint investigation.Solution dripped into the power strip, sparking occurred.Per risk documentation, potential root causes include personnel unaware of proper use of the device.
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: 22895085
• Report Number: 3014334038-2025-00118
• Device Sequence Number: 5916230
• Product Code: GWM
• UDI-Device Identifier: 10381780533788
• UDI-Public: 10381780533788
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2025

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 08/27/2025; 10/07/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 09/24/2025; 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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