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

Catalog Number	826820
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
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
A facility reported a the screen of a cerelink monitor is greyed out and the figures displayed are wildly out of range with each other and registering icps of between -30 and +55.Medical staff were unable to wake the patient up due to unreliable icps.The monitor was used since (b)(6) 2023.It was just greyed out like no matter what they did to it (ticking the green tick, pressing the 0, 20, 100 button and turning it off).
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h4, h6, h10 cerelink monitor was returned for evaluation: dhr - there is no indication that the production process may have contributed to this complaint.Failure analysis - after a few hours of testing the measurements, the unit displayed an abnormal reading/line.As a preventative measure, the lcd, digital and analog board as well as the battery were all replaced.After repair, the unit passed safety and functional testing.The complaint could be verified through failure analysis.Root cause - the complaint was confirmed in the complaint investigation.Likely root cause is, defective hardware (digital and analog boards and battery).
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 ; 6099362319
• MDR Report Key: 17435622
• Report Number: 3014334038-2023-00124
• Device Sequence Number: 6834748
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 01/11/2024
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2022
• 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
• Patient Sex: Unknown