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

Catalog Number	826634
Medical Device Problem Code	Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medwatch: (b)(4)."an icp express monitor failed within two (2) hours of placement.The device gave an error message of "transducer not detected," and icp express stopped displaying an icp reading.Biomed worked with the unit to troubleshoot the issue, but the monitor was no longer functional." "what was the original intended procedure? : monitoring of intracranial pressure (icp)"."what problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working)".
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: d4, d9, g3, g6, h2, h3, h6, h11.The icp monitor (id 826634) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
Additional Manufacturer Narrative
Updated fields: b4, d9, g3, h1, h10, h11.Follow up report to include "related report number" (b)(4).
Event or Problem Description
N/a.

• Brand Name: ICP EXPRESS
• Common Device Name: ICP EXPRESS - MONITOR
• 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 08540 ; 6099362319
• MDR Report Key: 18300085
• Report Number: 3014334038-2023-00187
• Device Sequence Number: 17932137
• Product Code: GWM
• UDI-Device Identifier: 10886704042341
• UDI-Public: 10886704042341
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2024

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: 826634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 05/17/2024; 07/11/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 06/07/2024; 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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