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

Catalog Number 425-00

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the device was not returned at the time of this report.The device history record (dhr) review did not show issues related to the complaint.The device was manufactured on 11/18/2009.A document assessment (fmea-08-037) was conducted and no changes were required.The reported complaint cannot be confirmed since the device sample is not available to perform a proper investigation, determine the root cause and assign corrective actions.If the device sample becomes available at a later date, this complaint will be updated accordingly.

Event Description

The event is reported as: the unit is overheating prior to use.There was no patient involvement reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also 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 neptune 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 failed this test with both limbs of the circuit alarming and a delta red light warming with audio.Further investigation showed that both the inspiratory and expiratory heating wire connectors had corrosion built up on the inside of the connector.This corrosive buildup could prevent a good connection for the circuit limbs.(con't) other remarks: based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies associated with the problem description.However, an electrical connection failure was discovered.A root cause for the failure could not be determined.

Event Description

The event is reported as: the unit is overheating prior to use.There was no patient involvement reported.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HEATED HUMIDIFICATION SYSTEM
• 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: 5393695
• MDR Text Key: 36920745
• Report Number: 3003898360-2016-00070
• 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: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 01/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/18/2016
• Initial Date FDA Received: 01/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2009
• 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