MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE; HUMIDIFIER, RESPIRATORY GAS

Catalog Number 425-00

Device Problem Device Stops Intermittently (1599)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4) device history record investigation did not show issues related to complaint.A record assessment (fmea) was performed and no update is required.Device was received for evaluation.Visual and physical structural testing revealed no significant findings, beyond that inherent of day to day use.No obvious physical damage noted.Device passed power-on self-test and temperature display accuracy test.The device was prepared for the functional bench test (tp-7) where water, an adult breathing circuit (880-36kit), 10 lpm of air pressure, low compliance column is connected to the unit for a real time operational scenario.Device successfully negotiated all pre-operational self-tests again and was functioning real time for 2 hours.The unit functioned without interruption.The complaint cannot be confirmed.Functional testing did not reveal any operational anomalies.No corrective/preventative actions will be assigned.Teleflex will continue to monitor and trend for similar customer complaints on these devices.

Event Description

Customer complaint alleges the respiratory therapist noticed the heater had shut down during use on a patient.No patient injury or consequence was reported.Patient condition reported as "fine".

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7529864
• MDR Text Key: 108798435
• Report Number: 3003898360-2018-00357
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1