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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA LIFESCIENCES(IRELAND) INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR; ICP MONITORING

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INTEGRA LIFESCIENCES(IRELAND) INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR; ICP MONITORING Back to Search Results
Catalog Number CAM02
Device Problems No Device Output (1435); Improper Flow or Infusion (2954)
Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Event Description
The cam02 inter-cranial pressure and temperature monitor experienced a catheter failure.The date of the incident was not provided.The device was not in contact with the patient and there was no injury, no death alleged, no revision or medical intervention and the patient was not prepped for surgery.It was unknown if there was a delay in surgery due to the product problem.Additional information has been requested.
 
Manufacturer Narrative
Investigation completed on 11/30/2016.-device history review, -trend analysis, -failure analysis.The device history review verified no anomalies that could be associated with the reported complaint.All the functionality tests were carried out accordingly and all results of the tests were recorded as within specification prior to the cam02 monitor been released.Trending analysis: a review of the customer complaints was competed using the following key words ¿catheter failure¿ and a root cause ¿icp flex cable¿ in the search criteria.The review encompassed dates 20-oct-2015 to 29-nov-2016.This is the only complaint occurrence which contained the search criteria.(b)(4).The failure analysis evaluation verified the complaint as valid.The service centre verified the catheter failure occurred due to a defective icp flex cable assembly.The cam02 monitor received a replacement icp flex cable assembly, was calibrated and safety tested.The results were reviewed as part of this evaluation, all the functionality tests were carried out accordingly and all results of the tests were recorded as within specification.The evaluation verified the complaint as valid; the cause of the complaint issue was identified as a defective icp flex cable assembly.Based on the complaint investigation completed it can be concluded no further evaluation is required.Future complaints will be continued to be monitored and trended.Conclusion: the evaluation verified the complaint as valid; the cause of the complaint issue was identified as a defective icp flex cable assembly which resulted in a catheter failure.
 
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Brand Name
INTER-CRANIAL PRESSURE AND TEMPERATURE MONITOR
Type of Device
ICP MONITORING
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
bina patel
311 enterprise drive
plainsboro, NJ 08536
6099362393
MDR Report Key6090894
MDR Text Key60027233
Report Number3006697299-2016-00201
Device Sequence Number1
Product Code GWM
Combination Product (y/n)N
PMA/PMN Number
K121573
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/17/2016
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 NumberCAM02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/17/2016
Initial Date FDA Received11/09/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/22/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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