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

Model Number	826851
Medical Device Problem Code	Output Problem (3005)
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
While demonstrating how to use the cerelink monitor an error message appeared saying that the system detected a problem either with the extension cable or sensor.No patient involvement.
Additional Manufacturer Narrative
The cerelink microsensor was returned for evaluation: dhr: lot: 3362996 (sn: (b)(6) met specifications when released.Failure analysis - no visible damage to the millar sensor, catheter or connector.Cerelink monitor reading was acceptable; icp express passed with reading 511.The device passed electronic, noise, linearity/hysteresis, and signal drift tests.The issue of the complaint was not confirmed.The root cause of the issue reported by customer could not be determined as the device worked correctly.
Event or Problem Description
N/a.

• Brand Name: UNKNOWN CERELINK
• Common Device Name: ICP MICRSOSENSORS - 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: 14085477
• Report Number: 3013886523-2022-00152
• Device Sequence Number: 2096693
• Product Code: GWM
• UDI-Device Identifier: 10886704075431
• UDI-Public: 10886704075431
• Combination Product (Y/N): N
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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 Expiration Date: 12/31/2020
• Device Model Number: 826851
• Device Catalogue Number: XXX - CERELINK
• Device Lot Number: 101072
• 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: 03/25/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/12/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2019
• 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
• Patient Sex: Unknown