MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LIMITED INTEGRA CAMINO ICP MONITOR; INTRACRANIAL PRESSURE MONITORING DEVICE

Model Number	CAM02
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported by the site/ user facility regional sales director: "the site is experiencing large swings in readings to the negative side after the catheter has been zero'd and placed.This is occurring possibly 24-48 hours into use.The customer has been able to swap monitors to get a positive reading".Additional information: monitor data logs showed multiple codes/ errors.The facility left cables and catheter connected to patient, switched monitor, and issue resolved.

• Brand Name: INTEGRA CAMINO ICP MONITOR
• Common Device Name: INTRACRANIAL PRESSURE MONITORING DEVICE
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LIMITED; ida business and; technology park; sragh tullamore, offaly ; EI
• MDR Report Key: 7810126
• Report Number: 2023988-2018-00049
• Device Sequence Number: 1143633
• Product Code: GWM
• UDI-Device Identifier: 10381780039310
• UDI-Public: 10381780039310
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K121573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: CAM02
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2018
• Initial Report FDA Received Date: 08/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention