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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE; HUMIDIFIER, RESPIRATORY GAS, (
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TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE; HUMIDIFIER, RESPIRATORY GAS, ( Back to Search Results
Catalog Number 425-00
Device Problem Excessive Heating (4030)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/02/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device involved has been received for evaluation, however the evaluation of said device is still in progress at the time of this report.A device history record investigation did not show issues related to this complaint.A record assessment (fmea) was conducted and no update is required.A follow up report will be submitted at the conclusion of the device evaluation.
 
Event Description
Customer complaint alleges the device continuously heats and does not stop at set point.Alleged issue reported occurred during 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 and was functioning real time.The temperature was set at 37 c.The set temperature was reached and maintained at 37 for two hours of uninterrupted operation.Based on the investigation performed, the reported complaint could not be confirmed.Functional testing did not reveal any operational anomalies.
 
Event Description
Customer complaint alleges the device continuously heats and does not stop at set point.Alleged issue reported occurred during use.No patient injury or consequence reported.Patient condition reported as fine.
 
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Brand Name
HUDSON CONCHA NEPTUNE
Type of Device
HUMIDIFIER, RESPIRATORY GAS, (
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8443364
MDR Text Key139547084
Report Number3003898360-2019-00297
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,health
Type of Report Initial,Followup
Report Date 03/02/2019
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 Number425-00
Device Lot NumberSN:617050503
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2019
Initial Date Manufacturer Received 03/02/2019
Initial Date FDA Received03/22/2019
Supplement Dates Manufacturer Received04/12/2019
Supplement Dates FDA Received04/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
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