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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 Problem Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/26/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the unit overheated.The unit was hot to touch and melted a portion of the circuit to the ventilator.No report of a patient injury or harm.
 
Manufacturer Narrative
The device sample was received by the manufacturer, but the investigation is incomplete.From the pictures provided it seems to be a "unit is overheating".No other defects were observed.Per dhr (device history record) the product concha neptune, serial (b)(4) was manufactured on 03/09/2012.The dhr investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes were required.
 
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Brand Name
HUDSON CONCHA NEPTUNE
Type of Device
HEATED HUMIDIFICATION SYSTEM
Manufacturer (Section D)
TELEFLEX
rtp NC 27709
Manufacturer Contact
margie burton, rn, ra
durham, NC 27709
9194334965
MDR Report Key4128741
MDR Text Key4935016
Report Number3003898360-2014-00727
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 User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/28/2014
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 Health Professional
Device Catalogue Number425-00
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer08/29/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/28/2014
Initial Date FDA Received09/24/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2012
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
780-35 CIRCUIT; PURITAN BENNETT 840 VENTILATOR
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