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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 Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/17/2014
Event Type  No Answer Provided  
Event Description
The event is reported as: the user facility reports that the heater (neptune) was involved with an alleged melted circuit.No patient injury or harm reported.
 
Manufacturer Narrative
The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.Per dhr (device history record) the product concha neptune, serial #(b)(4) manufactured on 04/09/2014.The dhr investigation did not show issues related to complaint.A (b)(4) 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 burto, rn, ra
p.o box 12600
durham, NC 27709
9194334965
MDR Report Key4051794
MDR Text Key4859976
Report Number3003898360-2014-00503
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 07/18/2014
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? No
Device Operator Health Professional
Device Catalogue Number425-00
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/28/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/18/2014
Initial Date FDA Received08/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2014
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
NEONATE BREATHING CIRCUIT; HUDSON 880-15 KIT
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