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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
Catalog Number 425-00
Device Problem Power Problem (3010)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/31/2020
Event Type  malfunction  
Manufacturer Narrative
(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 # 73a210001n) 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 "unit starts up and appears to work, but then shuts down.Respiratory intervened timely.No patient injury".No patient injury or desaturation reported.It was reported that the device was replaced.Patient condition reported as "fine".
 
Manufacturer Narrative
(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), 2-3 lpm of air pressure, and a 382-10 concha smart water column was connected to the unit for a real time operational scenario.In addition to the named test parameters, the neptune operational values were set as follows: temperature was set at 37 c, mode was invasive, full rainout on the moisture scale.The neptune was turned on, values set.The unit successfully negotiated all pre-operational self-tests again and was functioning real time.The unit functioned without any interruption or functional anomalies for approximately 1 hour.The complaint cannot be confirmed.The unit did not shut off.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.
 
Event Description
It was reported "unit starts up and appears to work, but then shuts down.Respiratory intervened timely.No patient injury".No patient injury or desaturation reported.It was reported that the device was replaced.Patient condition reported as "fine".
 
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Brand Name
HUDSON CONCHA NEPTUNE
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (
MDR Report Key11212075
MDR Text Key228425618
Report Number3003898360-2021-00015
Device Sequence Number1
Product Code BTT
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 12/31/2020
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 Number425-00
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2021
Initial Date Manufacturer Received 12/31/2020
Initial Date FDA Received01/22/2021
Supplement Dates Manufacturer Received02/17/2021
Supplement Dates FDA Received02/17/2021
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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