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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON CONCHA NEPTUNE; HEATED HUMIDIFICATION SYSTEM
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TELEFLEX HUDSON CONCHA NEPTUNE; HEATED HUMIDIFICATION SYSTEM Back to Search Results
Catalog Number 425-00
Device Problems Device Stops Intermittently (1599); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/11/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the unit shuts down and will turn back on for several minutes.No report of patient injury or harm.The patient's condition is reported as fine.
 
Manufacturer Narrative
A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.Per dhr (device history record) the product concha neptune, lot #608050857 was manufactured on 05/30/2008.The dhr investigation did not show issues related to complaint.A document assessment was conducted and no changes were required.The complaint can not be confirmed since the sample was not available for investigation, therefore, it is not possible to determine the root cause for the defect reported and a corrective action for it.Teleflex will continue to monitor and trend relating complaints.
 
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Brand Name
HUDSON CONCHA NEPTUNE
Type of Device
HEATED HUMIDIFICATION SYSTEM
Manufacturer (Section D)
TELEFLEX
tecate
MX 
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key3834591
MDR Text Key21488866
Report Number3003898360-2014-00144
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/24/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number425-00
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2008
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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