MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT,; N/A

Catalog Number CAM01

Device Problem Failure to Power Up (1476)

Patient Problem No Patient Involvement (2645)

Event Date 03/25/2016

Event Type  malfunction  

Event Description

It was reported that the loaner cam01 monitor was not turning on.Additional information received from the customer on 31mar2016 with the following: the problem was discovered during initial out of the box inspection.The unit taken out of the box and all cables attached.They tried to do an electrical safety test and found the unit would not turn on.Date of the initial inspection was (b)(6) 2016.The unit in question was never put into service; it never left the biomed shop.

Manufacturer Narrative

Integra has completed their internal investigation on 26apr2016.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: evaluation of device: the cam01 monitor did not turn on due to faulty crossbeam assembly (front cover lcd assembly).The reviewed service history documentation for cam01 monitor serial number (b)(4) has identified no impact on complaint incident.The dhr review has been deemed satisfactory.A minimum of 12 month review of cam01 monitor customer complaints was completed using the following key words "unit not working" and a root cause "faulty lcd assembly" in the search criteria.This review encompassed from dates (b)(6) 2015 to (b)(6) 2016.A total of (b)(4) complaints were reviewed of which (b)(4) complaints contained the search criteria.The analysis of the complaint investigations and root cause reports has concluded this complaint is the 1st identified complaint for the reported failure associated with the cam01 monitor due to faulty lcd assembly.No trend has been identified.The root cause of the cam01 monitor not turning on was due to faulty front cover lcd assembly.

• Brand Name: CAMINO ADVANCED MONITOR WITH ICP WAVEFORM, ICT,
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer (Section G): INTEGRA LIFESCIENCES(IRELAND); ida business&technology park; sragh, tullamore, co.offaly ; EI
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5586735
• MDR Text Key: 43862171
• Report Number: 3006697299-2016-00115
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K962928
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAM01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1