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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON CONCHA NEPUNE; HEATED HUMIDIFICATION SYSTEM
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TELEFLEX HUDSON CONCHA NEPUNE; HEATED HUMIDIFICATION SYSTEM Back to Search Results
Catalog Number 425-00
Device Problems Device Operates Differently Than Expected (2913); Power Problem (3010)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/01/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the unit powers down during pt use.The alleged issue occurs after the unit is in use for a while.No report of a pt injury or harm to the pt.
 
Manufacturer Narrative
The device sample was rec'd by the mfr, but the investigation is incomplete at the time of this report.Per dhr (device history record) the product concha neptune, lot #611120172 was manufactured on 12/07/2011.The dhr investigation did not show issues related to complaint.A document assessment was conducted and no changes were required.
 
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Brand Name
HUDSON CONCHA NEPUNE
Type of Device
HEATED HUMIDIFICATION SYSTEM
Manufacturer (Section D)
TELEFLEX
tecate
MX 
Manufacturer (Section G)
PROLONGACION MISION EUSEBIO
kino# 1316,rancho el descanso
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key3757224
MDR Text Key4467540
Report Number3003898360-2014-00142
Device Sequence Number1
Product Code BZE
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 Not Applicable
Type of Report Initial
Report Date 02/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number425-00
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/28/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received02/18/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2011
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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