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

Catalog Number 425-00

Device Problem Device Stops Intermittently (1599)

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

Event Date 12/13/2013

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that the device shuts off intermittently while in use with the puritan bennett ventilator.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.Per dhr (device history record), the product concha neptune, serial# (b)(4) was manufactured on 03/28/2008.The dhr investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes were required.The complaint can not be confirmed since the sample was not available for investigation at the time of this report, 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 MEDICAL; tecate, b.c. ; MX
• Manufacturer (Section G): TELEFLEX MEDICAL; prolongacion mision eusebio; kino # 1316,rancho el descanso; tecate, b.c., c.p. 2147 8; MX 21478
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3647375
• MDR Text Key: 4356023
• Report Number: 3003898360-2014-00013
• 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: 12/13/2013

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: 12/13/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2008
• 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
• Treatment: PB VENTILATOR