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

Model Number IPN913776

Device Problem Failure to Read Input Signal (1581)

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

(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 # 73c210012n) at the manufacturing facility and were functionally tested.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

It was reported "once powered on the heater will not stop alarming or allow the user to change temperature settings".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 passed the initial power connect test and navigated through the power-on self-test (p.O.S.T.) with no issues.The neptune failed the temperature display accuracy test as it did not recognize the temperature probes and did not display any temperature values.The unit was opened to inspect the temperature probe harness and temperature probe port.It was observed that harness 11809 (temperature probe harness) had damaged wires where it connected to the temperature probe port.The red wire was disconnected from the black shrink tubing.Upon further inspection, all 3 wires of the harness were significantly loose where they connect to the temperature probe port and were able to be easily removed.Visual inspection of the wires showed that it appeared to be some type of shear force that broke the wires.In order for the red wire to be damaged in this way, it was determined that this is likely from an attempt by the customer to open or manipulate the unit.Concha neptune user manual states: "do not disassemble.Refer all servicing to teleflex medical or authorized repair center." the complaint is confirmed.The investigation revealed that the temperature probe harness had wires that were damaged where the harness connects to the temperature probe port.Due to this, the unit was not able to display temperatures from the port and the unit alarmed prior to use.Since the neptunes are 100% functionally tested during manufacturing assembly, it is unlikely that this failure was present at the time of release.A device history record review was performed with no evidence to suggest a manufacturing related issue.It appears that the customer attempted to open or manipulate the unit.Based upon the damage observed, it appears that intentional user error caused or contributed to this event.An in-service has been requested.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

It was reported "once powered on the heater will not stop alarming or allow the user to change temperature settings".No patient involvement reported.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 11696517
• MDR Text Key: 258940331
• Report Number: 3003898360-2021-00380
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 14026704646811
• UDI-Public: 14026704646811
• 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: 03/31/2021

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 Operator: No Information
• Device Model Number: IPN913776
• Device Catalogue Number: 425-00
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 05/20/2021
• Supplement Dates FDA Received: 05/21/2021
• 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