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

Model Number	IPN913776
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2021
Type of Reportable Event	Malfunction
Additional 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 # 73h210002r) at the manufacturing facility and were inspected.During the test, issue reported "unit is not heating prior to use" was not observed in the current manufacturing process.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 or Problem Description
It was reported that the unit "would not heat".No patient involvement reported.

• Brand Name: HUDSON CONCHA NEPTUNE
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (
• MDR Report Key: 12647034
• Report Number: 3003898360-2021-00948
• Device Sequence Number: 13776978
• Product Code: BTT
• UDI-Device Identifier: 14026704646811
• UDI-Public: 14026704646811
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K131912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/27/2021

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
• Operator of Device: No Information
• Device Model Number: IPN913776
• Device Catalogue Number: 425-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 10/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1