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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON CONCHA NEPTUNE; HEATED HUMIDIFICAITON SYSTEM
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TELEFLEX HUDSON CONCHA NEPTUNE; HEATED HUMIDIFICAITON SYSTEM Back to Search Results
Catalog Number 425-00
Device Problem Display or Visual Feedback Problem (1184)
Patient Problem No Patient Involvement (2645)
Event Date 09/16/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the unit has an electrical issue on display.
 
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) was manufactured on 07/29/2011.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 HUMIDIFICAITON SYSTEM
Manufacturer (Section D)
TELEFLEX
rtp NC 27709
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
MDR Report Key4148490
MDR Text Key20776232
Report Number3003898360-2014-00776
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 Not Applicable
Type of Report Initial
Report Date 09/16/2014
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 Other
Device Catalogue Number425-00
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer09/23/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/16/2014
Initial Date FDA Received10/02/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2011
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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