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U.S. Department of Health and Human Services

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

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INTEGRA LIFESCIENCES(IRELAND) PRE-AMP CABLE, MPM-1. CONNECTS MONITOR TO CATHET; N/A Back to Search Results
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.
 
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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 Key6125834
MDR Text Key61025157
Report Number3006697299-2016-00211
Device Sequence Number1
Product Code GWM
Combination Product (y/n)N
PMA/PMN Number
K962928
Number of Events Reported1
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 NumberPAC1
Device Lot NumberTL-345703
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/03/2016
Initial Date FDA Received11/23/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received01/16/2017
02/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
CAMINO MONITOR
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