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

Catalog Number 395-90

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.A verification of failure mode reported in the current manufacturing process was conducted as follows: (b)(4) devices were taken from the current production p/n 395-90 conchatherm neptune, dual thermistor, ad lot # 73a1900310, and visually inspected.During testing issue reported was not observed in the current manufacturing process.A device history record review could not be conducted as the lot number was reported as unknown.Customer complaint cannot be confirmed.Root cause and corrective actions cannot be determined.For a thorough and proper investigation, it is necessary to have the device sample involved.If the device sample becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges "patient was on comfort flo therapy and the temp probe fell out of the circuit"."the heater did not audible alarm".(alarm issue captured in mfr.Rpt.#3003898360-2019-00162).

Manufacturer Narrative

Qn#(b)(4).One (1) 395-90 conchatherm neptune, dual thermistor, ad was received for investigation.At visual inspection the temperature probe set was examined for any signs of physical abuse/misuse/damage.None were noted.An 880-36kit breathing circuit was used to test the "fit" of the temperature probes themselves.One temperature probe was inserted in the temperature probe port of the circuit at the patient "y".Approximately half of the temperature probe went into the circuit before the probe tightened and could not be pushed any further.The other half of the temperature probe set was inserted into the temperature probe port on the column end.Again, about half way in the temperature probe tightened up.A reasonable force was required to pull the temperature probes out of the ports.A device history record review was conducted on the serial number of the returned unit (serial# (b)(4)).No issues were found that could relate to the reported complaint.Based on the investigation, the report that the probes fell out of the circuit cannot be confirmed.There were no issues found with the returned unit.

Event Description

Customer complaint alleges "patient was on comfort flo therapy and the temp probe fell out of the circuit"."the heater did not audible alarm".(alarm issue captured in mfr.Rpt.#3003898360-2019-00162).

• Brand Name: HUDSON CONCHATHERM NEPTUNE, DUAL THERMISTOR
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8310543
• MDR Text Key: 135198270
• Report Number: 3003898360-2019-00163
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2019
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NEPTUNE HEATER. COMFORT FLOW CIRCUIT.; NEPTUNE HEATER. COMFORT FLOW CIRCUIT.; NEPTUNE HEATER. COMFORT FLOW CIRCUIT.