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

Catalog Number 395-90

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2018

Event Type  malfunction  

Manufacturer Narrative

Qn# (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, (b)(4)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 Description

Customer complaint alleges the device probe was not functioning during a patient use.No patient harm reported.Patient condition reported as fine.

Manufacturer Narrative

(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 # (b)(4)).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 finished goods product and will be sent to the manufacturer for further evaluation.

Event 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
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7873216
• MDR Text Key: 120245825
• Report Number: 3003898360-2018-00750
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K063758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Catalogue Number: 395-90
• Device Lot Number: SN:616121083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2018
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/13/2018
• Supplement Dates Manufacturer Received: 10/10/2018
• Supplement Dates FDA Received: 10/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.