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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON CONCHA NEPTUNE; HUMIDIFIER, RESPIRATORY GAS, (
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HUDSON CONCHA NEPTUNE; HUMIDIFIER, RESPIRATORY GAS, ( Back to Search Results
Model Number IPN913776
Device Problem Overheating of Device (1437)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
Event Type  malfunction  
Manufacturer Narrative
Qn#: (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 # 73d210011n) at the manufacturing facility and were functionally tested.No issues were encountered during the functional testing.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 Description
It was reported that a burning smell was coming from the concha neptune unit and it was very hot to the touch with "smoke" coming from the concha column.The patient was not harmed in this event.Patient condition reported as "fine".
 
Event Description
It was reported that a burning smell was coming from the concha neptune unit and it was very hot to the touch with "smoke" coming from the concha column.The patient was not harmed in this event.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).The customer returned one concha neptune, 425-00, for investigation.The unit was also returned with the conchasmart column, oxygen diluter, and part of the breathing circuit.A visual exam was performed and it was observed there was a crack in the rear mounting bracket.No other defects were observed.Functional testing was performed and the unit was connected to 120vac.The unit passed the initial power connect test; however, the unit failed the power-on self-test (p.O.S.T.).The unit was opened and the power supply board was replaced with a known good lab inventory power supply board.It was observed that there was significant dust/debris inside the unit.There was also slight discoloration on the wire harness.The unit was now able to navigate 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 a full functional bench test in an attempt to replicate the reported defect.A water reservoir bottle, an adult breathing circuit (880-36kit), the returned conchasmart column, the returned oxygen diluter, and dual temperature probes were connected to the unit.3 lpm of air flow were supplied to the unit for a real time operational scenario.The unit successfully navigated all pre-operational self-tests again and was functioning in real time.The settings were set to full rainout , invasive, at 37 degrees c.The unit functioned without any interruption or functional anomalies for ~1.0 hour.The unit was re-opened to further investigate all internal components.No evidence of burning or overheating was observed with the unit.It is possible that the buildup of dust/debris that was found inside the unit could cause a burning smell, however no smell or smoke was observed during this investigation.Buildup of dust/debris can occur if the unit is mounted low to the floor or stored in an area that promotes dust build up.Although the complaint cannot be confirmed, the unit is defective as a faulty power supply board was observed.A device history record review was performed with no evidence to suggest a manufacturing related issue.Each concha neptune device is inspected 100% during manufacturing assembly, it is unlikely that this defect was present at the time of release.The sample was manufactured in 2013 and was designed for a minimum of 5 years.Based on the information available, it appears that unintentional user error - normal wear caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.
 
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Brand Name
HUDSON CONCHA NEPTUNE
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (
MDR Report Key11832971
MDR Text Key250912993
Report Number3003898360-2021-00442
Device Sequence Number1
Product Code BTT
UDI-Device Identifier14026704646811
UDI-Public14026704646811
Combination Product (y/n)N
PMA/PMN Number
K131912
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN913776
Device Catalogue Number425-00
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2021
Date Manufacturer Received06/10/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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