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

Catalog Number 425-00

Device Problem Failure to Power Up (1476)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2013

Event Type  malfunction  

Event Description

The events is reported as: the customer alleges that the unit will not power on.No report of a patient injury or delay in treatment.

Manufacturer Narrative

A visual, dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A document assessment (fmea) was conducted and no changes were required.Per dhr (device history record) the product concha neptune, serial #(b)(4) was manufactured on 12/15/2011.The dhr investigation did not show issues related to complaint.The complaint can not be confirmed since the sample was not available for investigation, therefore, it is not possible 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 MEDICAL; tecate ; MX
• Manufacturer (Section G): TELEFLEX; prolongacion mision eusebio; kino # 1316,rancho el descanso; tecate, b.c., cp 2147 8; MX 21478
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3647327
• MDR Text Key: 4286705
• Report Number: 3003898360-2014-00029
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2014
• 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: 12/19/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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