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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
1 of 2 reports.Other mfg report number: 3013886523-2024-00301.A facility reported a patient went to a scan and returning from scan, the sensor was unable to reconnect.Message: "sensor/cable failure".The cables were replaced; however, the issue persisted; therefore, the sensor was removed.Medical staff was unable to power the monitor off.When power button is pressed the monitor displays shutdown message.The screen goes blank.However the monitor then just re-boots and powers up by itself.Tried to shutdown the monitor multiple times but the monitor just keeps re-booting.Fault has been corrected before by carrying out this procedure.However this cannot be done on the ward when corrected to a patient.
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
The 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 - the problem indicated by the customer has been not confirmed.The cerelink device was tested with a test cable and the monitor is working properly.There was no fault found in the monitor.Root cause - the returned unit was tested with a test cable and is working properly.There was no fault found in the monitor.However, a potential cause of the reported error message may have been related to sensor or an inadequate cable connection.A potential cause of the reported inability to power the unit off may have been related to an inadequate cable connection.
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: 20313414
• Report Number: 3014334038-2024-00198
• Device Sequence Number: 15399439
• 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): 01/02/2025

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: 08/30/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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