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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 Emits Odor (1425); Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/28/2014
Event Type  malfunction  
Event Description
The event as reported as: the clinician alleges noticing a burning smell coming from the heater.Sparks were noted from the heater at the site of the fan.The device was removed without further incident.No injuries reported.
 
Manufacturer Narrative
The device sample was received by the mfr, but the investigation is incomplete at the time of this report.Per dhr (device history record) the product concha neptune, serial #(b)(4) was manufactured on 07/06/2010.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 NEPTUNE
Type of Device
HEATED HUMIDIFICATION SYSTEM
Manufacturer (Section D)
TELEFLEX
tecate
MX 
Manufacturer Contact
margie burton, rn, regulatory af
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key3824753
MDR Text Key21175822
Report Number3003898360-2014-00087
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 Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/28/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2014
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
Date Returned to Manufacturer02/05/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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