MAUDE Adverse Event Report: INTEGRA LIFESCIENCES (IRELAND) LIMITED MONITOR ADAPT CABLE, ICP, HP, MERLIN SERIES

Model Number	ICP39
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Bedside monitoring cable icp39 not exporting icp values.Switched out the pmiompm1 and the icp39 cables.Problem stays with the icp39 cable.Additional information has been requested.
Additional Manufacturer Narrative
Section g 1,2- updated contact office information.Several attempts were made to obtain additional information, however no response was received.Follow-up made: 04may2018: no reponse.Follow-up made: 24 may2018: no reponse.Natus completed their evaluation on 13august2018.Investigation results included the following: complaints history review/ complaint rate.Risk management review.Review of past capas/ capa determination.Results: the customer's complaint "bedside monitoring cable icp39 not exporting icp values" could not be confirmed.The cable was returned for evaluation however it was misplaced at the service center and cannot be located.Dhr review: the lot number for the cable was not reported however, the customer reported the cam02 unit's serial number the dhr review for the monitor found no anomalies related to the customer's complaint.Complaint history review/trend analysis: based on the complaint description a review of complaints was performed using the following key word improper function " in the search criteria.The review encompassed dates jun-2016 through jun-2018.There were zero (o) confirmed complaints during this time.Based on the number of sales (jun-2016 through may2018), 306 units, the incident rate is 0.0%.Risk management review: the cam02 relationship of device characteristics to hazards (table a) identifies the complaint as "control/lnteraction with other devices", with the sequence of events of "improper interaction with bedside monitor." resulting in a hazard of "incorrect diagnosis" (dia-005), harm of "inconvenience to user" and severity of "negligible".Capa: n/a (no capa issued since nov-2016).Root cause: unable to evaluate-device was received, however it was misplaced at the service center and could not be located.This complaint is now deemed closed.

• Brand Name: MONITOR ADAPT CABLE, ICP, HP, MERLIN SERIES
• Common Device Name: MONITOR ADAPT CABLE, ICP, HP, MERLIN SERIES
• Manufacturer (Section D): INTEGRA LIFESCIENCES (IRELAND) LIMITED; ida business and technology; park; sragh tullamore, offaly ; EI
• MDR Report Key: 7559044
• Report Number: 2023988-2018-00025
• Device Sequence Number: 13511245
• Product Code: GWM
• UDI-Device Identifier: 10381780039730
• UDI-Public: 10381780039730
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K962928
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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: Health Professional
• Device Model Number: ICP39
• Device Catalogue Number: ICP39
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 08/14/2018
• 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