MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) PRE-AMP CABLE, MPM-1. CONNECTS MONITOR TO CATHET; N/A

Catalog Number PAC1

Device Problems No Device Output (1435); Device Inoperable (1663); Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

The pac1 pre-amp cable was connected to a cam02 monitor and it was not working.There was no patient contact, injury, revision or medical intervention.The incident did not cause a delay in surgery.Images of the cable connected to the functioning cam02 monitor were provided.

Manufacturer Narrative

Investigation completed (b)(6) 2016.The dhr review was completed for camcabl cable serial number (b)(4), work order (b)(4), lot number tl-345703.No non-conformance reports were raised during the manufacturing process for this cable.The dhr review has been deemed satisfactory.Date of manufacture: jan-2016.Product was not returned after several documented attempts.Therefore, an evaluation was unable to be performed.Root cause not determined; product not returned.

Manufacturer Narrative

Integra completed its internal investigation 02/21/2017.The investigation included: method: -dhr review.- review of complaint management database for similar complaints.-visual evaluation.A minimum of 12-month review of camcabl cable customer complaints was completed using the following key words and ¿functionally defective cable ¿ root cause not determined¿ in search criteria.The key word search review of the complaints contained all and/or part of the key words to complete a comprehensive trend review.This review encompassed dates 06-nov-2015 to 15-feb-2017.A total of 23 complaints were reviewed of which 7 complaints contained the search criteria.Failure analysis: the reported failure was confirmed; during investigation the camcabl cable did not read the test catheter (no icp readings observed on test monitor); however, the root cause of the failure was not determined by service centre.During the evaluation, the cam02 monitor¿s touchscreen was confirmed faulty due to an air gap incident.The air gap causes an intermittent contact between the touch surfaces thus causing the failure of the screen to work.Conclusion: product was returned and the evaluation verified the complaint incident ¿connected with cam02 does not work¿ as valid.Root cause not determined; camcabl cable did not read the test catheter (no icp readings observed on test monitor); however, the root cause of the failure was not determined, thus trended as functionally defective cable - root cause not determined.

• Brand Name: PRE-AMP CABLE, MPM-1. CONNECTS MONITOR TO CATHET
• 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: 6125834
• MDR Text Key: 61025157
• Report Number: 3006697299-2016-00211
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: PAC1
• Device Lot Number: TL-345703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/16/2017; 02/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2016
• 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
• Treatment: CAMINO MONITOR