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

Catalog Number	826634
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported an intracranial pressure (icp) monitor (id 826634) was not reading correctly and it was overheating.No patient contact/injury reported.
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
Updated fields: d1, d2a, d4, d9, g3, g6, h2, h3, h4, h11.The icp monitor (id 826634) was returned for evaluation.Device history review: no anomalies were identified that occurred during the manufacture or packaging of the device.Failure analysis: during the evaluation the lcd, housing and psu suffered physical damage.The icp console will need a psu, battery, housing, and lcd to correct the repair.Replaced the psu, battery, housing, and lcd to correct the problem.Performed an evaluation and function test.The icp console passed all tests.The complaint was confirmed.Root cause analysis: the likely root cause is physical damage throughout the unit.

• Brand Name: ICP EXPRESS
• Common Device Name: ICP EXPRESS - MONITOR
• 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: 23782485
• Report Number: 3014334038-2025-00152
• Device Sequence Number: 14722877
• Product Code: GWM
• UDI-Device Identifier: 10381780520443
• UDI-Public: 10381780520443
• Combination Product (Y/N): N
• PMA/510(K) Number: K945585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: 826634
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2013
• 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