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

Catalog Number	826820
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 cerelink monitor ((b)(6).) showing out of range values and continued to occur after changing the cables, power supply and moving it away from other devices.Over the weekend, the value became negative (-4).Troubleshooting was done by electrocardiogram (ecg) lead changed, machine plugged into wall and keeping it away from other devices however, it was not resolved.Eventually the numbers became positive but wide swings in the values 2-30, with the low values not in line with the imaging and clinical activities.No patient injury reported.Customer stated that it may have been user error.No additional information available.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: d4, d9, g3, g6, h2, h3, h6, h11.The cerelink monitor (id (b)(4) 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; however, the customer reported that they did not feel a need to continue pursuing an investigation as they believe there may have been user error causing the issue.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.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Updated fields: b5, d8, d9, g1, g3, g6, h1, h2, h3, h9.Follow-up submitted to include "correction/removal rpt number" (3014334038-10/05/2023-002-r) (h9).

• 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 08540 ; 6099362319
• MDR Report Key: 18383947
• Report Number: 3014334038-2023-00195
• Device Sequence Number: 14505644
• Product Code: GWM
• UDI-Device Identifier: 10886704075622
• UDI-Public: 10886704075622
• 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: 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: 826820
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 05/28/2024; 07/11/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 06/16/2024; 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3014334038-10/05/2023-00
• Patient Sequence Number: 1
• Patient Sex: Unknown