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	Insufficient Information (4580)
Date of Event	04/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
1 of 3 reports (same patient, same event, different products).Other mfg report numbers: 3006697299-2024-00055 and 3013886523-2024-00138.A facility reported a cerelink monitor (id (b)(4) displayed error code 1019 and sensor or extension cable failure.The expected output value was not generated during bit.Registrar reviewed and was unable to calibrate the monitor and it was showing wrong values.Monitor was turned off again due to error message.The sensor was explanted and replaced.The cable used with the system is cerelink icp ext cable (b)(4).
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
Cerelink monitor was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - functional testing of the monitor, with the returned cable and power supply, did not confirm the reported failure or error.Review of the unit's error log did not confirm multiple instances of error 1019.The unit has the latest version of the digital board, analog board, and touchscreen.As a preventive measure, the analog board was replaced.Root cause - functional testing of the monitor, with the returned cable and power supply, was not able to duplicate the reported failure or error.A potential cause of the reported failure may have been related to the system set-up and security of the connections.
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: 19282316
• Report Number: 3014334038-2024-00097
• Device Sequence Number: 7577733
• 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): 08/22/2024

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: 04/22/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown