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

Catalog Number 425-00

Device Problem Insufficient Heating (1287)

Patient Problem No Information (3190)

Event Date 09/10/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of the reported failure mode was conducted and 8 devices were taken from current production (425-00 concha neptune lot #73j200004n) at the manufacturing facility, and were functionally inspected.No issues were encountered during the functional testing.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The complaint is reported as: the unit is not heating.It is unknown at this time when the issue was detected.No patient involvement or injury reported.

Event Description

The complaint is reported as: the unit is not heating.It is unknown at this time when the issue was detected.No patient involvement or injury reported.

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.The unit was not able to navigate through the power-on self-test.The unit alarmed and displayed a red wrench.The unit was opened and the power supply board was switched with a known good one.Still the unit displayed a red wrench and alarmed during the power-on self-test.The power control board was removed and checked for defects.No damage was observed to the control board.The resistance across the thermal fuse on harness 11805 was measured to be 0.2 ohms, which is within the proper range of 0.2-0.4 ohms.The thermal switch on harness 11805 was measured to be ol ohms indicating that the switch was open.This switch is only supposed to be open , breaking the electrical continuity if the neptune overheats.The neptune was at room temperature so the switch should have been closed.The unit has a faulty thermal switch.The complaint has been confirmed.The investigation revealed a faulty thermal switch.Since the neptunes are 100% functionally tested during manufacturing assembly, it is unlikely that the failure was present at the time of release.A device history record review was performed with no evidence to suggest a manufacturing related issue.The unit was manufactured in 2011 and was designed for a minimum of 5 years.The root cause for the failure is normal wear.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 10579970
• MDR Text Key: 208334004
• Report Number: 3003898360-2020-00775
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K131912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• 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: 09/22/2020
• Date Manufacturer Received: 10/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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