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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE; HEATED HUMIDIFICATION SYSTEM
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TELEFLEX MEDICAL HUDSON CONCHA NEPTUNE; HEATED HUMIDIFICATION SYSTEM Back to Search Results
Catalog Number 425-00
Device Problem Failure to Power Up (1476)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that the device will not turn on.The alleged defect occurred during pre-test/set-up.No report of a patient injury or delay in treatment.
 
Manufacturer Narrative
The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.Per the dhr (device history record) review the product concha neptune, serial number (b)(4) was manufactured on 09/17/2008.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 MEDICAL
tecate
MX 
Manufacturer Contact
margie burton, rn
p.o. box 12600
durham, NC 27709
9194334965
MDR Report Key3865244
MDR Text Key4567990
Report Number3003898360-2014-00071
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
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 01/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/07/2014
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 Manufacturer02/03/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received01/21/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2008
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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