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

Catalog Number CAM02

Device Problems High Readings (2459); Improper Device Output (2953)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This report is in reference to the 4 monitors (serial numbers unknown).The user facility reported that they had numerous issues with the readings when using their camino monitors.There was a total of 5 camino monitors that exhibited odd readings.However, the customer could not provide the specific serial numbers for four of the monitors.There have not been any subsequent issues with any of their camino monitors since the original submission of the first complaint (mfg.Report number: 3006697299-2017-00115) additional information received from the integra sales representative on 10aug2017: the sales representative confirmed that there was no patient injury with any of these 4 monitors.It was believed that it could just be catheter insertion technique by the customer.Specific serial numbers of the 4 monitors were not known since the monitors were put back in circulation.Product/technique in-service has been scheduled by integra with the customer.

Manufacturer Narrative

Investigation completed 08/17/2017.A review of cam02 monitor customer complaints was completed using the following key words sporadic readings, negative numbers, and high numbers in the search criteria.The review encompassed dates 14-aug-2016 to 14-aug -2017.Two complaints were identified; both complaints were reported from the same facility for the same failure.Additional information provided from sales representative, "it was believed alleged failures were due to the catheter insertion technique used by the customer." as a result, product/technique in-service has been scheduled by integra with the customer.Rate of occurrence: during the time period (b)(6) to (b)(6), the global product usage for cam02 monitors was calculated as (b)(6) usages, using the total quantity of cam02 monitor catheter sales sold to calculate the quantity of usages.1 catheter is used per procedure, and is used as a means of quantifying the number of procedures undertaken.The quantity of complaints in the complaint review (2) can therefore be calculated as (b)(4).Product was not returned (returned to hospital circulation) so the evaluation was unable to be performed.Therefore, an investigation for cause was unable to be performed.

• 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: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6795488
• MDR Text Key: 82924566
• Report Number: 3006697299-2017-00125
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K121573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CAM02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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