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

Model Number IPN913776

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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

It was reported the unit is "not powering on".No patient involvement reported.

Event Description

It was reported the unit is "not powering on".No patient involvement reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no major defects observed.Functional testing was performed and the unit was connected to 120vac.The unit did not pass the initial power connect test or the power-on self-test (p.O.S.T.).The power button was not illuminating and when pressed , the unit did not power on.The unit was opened, and it was noted that the power supply board was burnt in the back middle of the board.Additionally , one of the power harnesses broke during removal of the power supply board, so it was not possible to replace the burnt board with a known good lab inventory board.R & d was contacted and they presented a possible root cause related to the melted solder spread out on the board, which could cause the unit to overheat and fail.The board was sent back to the pcb supplier for further testing.The supplier investigation revealed a possible root cause related to one of the burnt components on the board puncturing and therefore shorting with the metal base plate located under the board inside the unit.This could explain why the board was found to be functioning correctly during initial manufacturing, but later failed shortly after assembly within the unit.The shorting could have also been caused by insufficient distance between the board and the base plate, or potentially by longer leads being left on the bottom of the board which would have been able to touch the base plate after assembly.Multiple potential root causes have been presented by r & d as well as the supplier.Therefore, it could not be determined exactly how or when the board experienced the failure based on the results of this investigation.The root cause will be listed as undetermined.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 12477930
• MDR Text Key: 271685154
• Report Number: 3003898360-2021-00826
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 14026704646811
• UDI-Public: 14026704646811
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

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 Model Number: IPN913776
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/15/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/10/2022
• 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: Reuse
• Patient Sequence Number: 1