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

Catalog Number	826636
Medical Device Problem Code	Electrical Shorting (2926)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2024
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 that during a procedure, an icp cable (id (b)(6) was with short circuit.As a result, a new cable from the same device was used to connect the icp monitor (id (b)(6).No adverse consequences were reported; however, a 10-minute delay was noted.
Additional Manufacturer Narrative
The icp express cable (id 826636) was returned for evaluation.Device history record (dhr) ¿ the batch record was reviewed for any anomalies or non-conformances related to the finished device, and none were identified.Failure analysis - the cable was tested using an icp express and transducer simulator.When the cable was connected to the icp express and transducer, the icp express went into an error state and no longer functioned.The icp express stopped working.The cable was then inspected, and the sockets/pins were checked for continuity.One of the pins that should not have been active was, which is consistent with the reported short circuit.Root cause analysis - the cable failed during functional testing.A visual and functional test of the socket/pins was conducted and identified a failing pin, consistent with the reported short circuit.A potential cause of the failure may be related to damage incurred during handling, storage, and/or use.
Event or Problem Description
N/a.

• Brand Name: ICP EXPRESS CABLE
• Common Device Name: ICP EXPRESS - CABLES
• 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: 19054540
• Report Number: 3014334038-2024-00065
• Device Sequence Number: 18184538
• Product Code: GWM
• UDI-Device Identifier: 10381780520481
• UDI-Public: 10381780520481
• 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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: 826636
• Device Lot Number: 510722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ICP MONITOR (ID 826635).
• Patient Sex: Unknown