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

Catalog Number 425-00

Device Problems Electrical /Electronic Property Problem (1198); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in this complaint could not be conducted since the device was not received by the manufacturer at the time of this report.A device history record investigation did not show issues related to the complaint.A record assessment (fmea) was conducted and no changes required.Customer complaint cannot be confirmed based on the information received at the time of this report.It is necessary to receive the device sample to perform a proper investigation and confirm the alleged defect.Corrective actions cannot be established at this time.If the device sample becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges: "the device shut off on during patient use." alleged malfunction reported as occurring during a patient use.There was no report of patient harm.There was no report of medical intervention.Patient condition was reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was performed and the unit was connected to 110vac.The unit passed the initial power connect test and navigated through the power-on self-test (p.O.S.T.) with no issues.During the temperature display accuracy test the unit displayed the correct temperatures and properly alarmed in the high temperature scenario.The unit was prepared for the functional bench test where water, an adult breathing circuit (880-36kit), 10 lpm of air pressure, and a low compliance column is connected to the unit for a real time operational scenario.The unit successfully negotiated all pre-operational self-tests again and was functioning real time.The unit functioned without interruption for two hours.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.

Event Description

Customer complaint alleges: "the device shut off on during patient use." alleged malfunction reported as occurring during a patient use.There was no report of patient harm.There was no report of medical intervention.Patient condition was reported as "fine".

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: RESPIRATORY GAS HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 6741532
• MDR Text Key: 80956675
• Report Number: 3003898360-2017-00836
• 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,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2008
• 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