MAUDE Adverse Event Report: TELEFLEX HUDSON CONCHA NEPTUNE; HEATED HUMIDIFICATION SYSTEM

Catalog Number 425-00

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

The event is reported as: the unit is not working.The user facility could not provide any additional information regarding the circumstances with the device.The user facility could not provide information as to when the alleged issue occurred and if there was patient involvement.

Manufacturer Narrative

A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.Per dhr (device history record) the product concha neptune, serial # (b)(4) was manufactured on 08/17/2012.The dhr investigation did not show issues related to complaint.A document assessment was conducted and no changes were required.The complaint cannot be confirmed since the sample was not available for investigation; therefore, it is not possible to determine the root cause for the defect reported and a corrective action for it.Teleflex will continue to monitor and trend relating complaints.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HEATED HUMIDIFICATION SYSTEM
• Manufacturer (Section D): TELEFLEX; tecate ; MX
• Manufacturer Contact: margie burton, rn, reg affairs ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3826190
• MDR Text Key: 16555156
• Report Number: 3003898360-2014-00101
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1