MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A; HUMIDIFIER, RESPIRATORY GAS, (

Catalog Number	395-90
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.However, 20 devices were taken from the current production p/n 395-90 conchatherm neptune, dual thermistor, ad lot # 73h1800167.The samples were visually inspected.During testing, the issue reported was not observed in the current manufacturing process.A device history record investigation did not show issues related to this complaint.A record assessment (fmea) was performed and no update is required.Customer complaint cannot be confirmed due the device sample is not available to perform a proper investigation and determine the root cause.Corrective actions cannot be established.If the device sample becomes available at a later date, this report will be updated accordingly.
Event or Problem Description
Customer complaint alleges the device probe was not functioning during a patient use.No patient harm reported.Patient condition reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).One (1) 395-90 conchatherm neptune, dual thermistor, ad was received for investigation.A visual examination was performed to determine if the probe sustained any abuse/misuse/damage.No damage was noted.The temperature probe was connected to a known functioning neptune heater 425-00 (serial # 615070237).The temperature sensors were inserted into the temperature ports of an 880-36kit breathing circuit.The temperature probe set was connected to the neptune heater via the three pin plug connection point on the lower front face of the neptune heater.The neptune heater was turned on and immediately displayed a failed temperature reading along with an audible alarm.The suspect probe was removed and a known functioning temperature probe was connected to the neptune heater.Upon restarting the neptune, the heater moved through all of the self-tests and diagnostics without interruption and moved to the operation setup mode.Based on the investigation performed, the reported complaint has been confirmed.The 395-90 temperature probe is inoperable.While the temperature probe has been confirmed as inoperable, the root cause cannot be established at this time.This product is a purchased finish goods product and will be sent to the manufacturer for further evaluation.
Event or Problem Description
Customer complaint alleges the device probe was not functioning during a patient use.No patient harm reported.Patient condition reported as fine.

• Brand Name: HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR, A
• Common Device Name: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7873418
• Report Number: 3003898360-2018-00749
• Device Sequence Number: 1925331
• Product Code: BTT
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K063758
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2018

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 Catalogue Number: 395-90
• Device Lot Number: SN:616120936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.