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

Catalog Number 425-00

Device Problem False Alarm (1013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

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.However, nine devices were taken from the current production, and functionally inspected.During testing, the issue "constantly alarming during use" reported was not observed in the current manufacturing process.A device history record investigation for serial number reported did not any show issues related to this complaint.A record assessment (fmea) was conducted and no update is required.Customer complaint cannot be confirmed.Root cause and corrective actions cannot be determined.If the device sample becomes available at a later date, this report will be updated accordingly.

Event Description

Customer complaint alleges the "orange water light constantly alarming, but temperature remained the same, water bottle full".Issue reported as occurred during patient use.No patient injury or consequence reported.Patient condition reported as fine.

Event Description

Customer complaint alleges the "orange water light constantly alarming, but temperature remained the same, water bottle full".Issue reported as occurred during patient use.No patient injury or consequence reported.Patient condition reported as fine.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and there were no defects observed.Functional testing was performed and the unit was connected to 110vac.The unit passed the initial power connect test and navigated through the power-on self-test (p.O.S.T.) with no issues.During the temperature display accuracy test the unit displayed the correct temperatures and properly alarmed in the high temperature scenario.The unit was prepared for the functional bench test where water, an adult breathing circuit (880-36kit), 10 lpm of air pressure, and a 382-10 universal water column is connected to the unit for a real time operational scenario.The unit successfully negotiated all pre-operational self-tests again.The testing parameters were set as such: full rainout, invasive mode , temperature set at 37 c.The unit functioned without any interruption or functional anomalies for ~2.0 hours.No alarms were activated beyond normal self-diagnostic testing.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.

• Brand Name: HUDSON CONCHA NEPTUNE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8424086
• MDR Text Key: 138898247
• Report Number: 3003898360-2019-00269
• Device Sequence Number: 1
• Product Code: BTT
• 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: 02/20/2019

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: 425-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2019
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: WATER BOTTLE.; WATER BOTTLE.; WATER BOTTLE.