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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 Overheating of Device (1437)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/16/2015
Event Type  malfunction  
Event Description
The customer alleges that the device overheated during use on patient.No report of a patient injury.
 
Manufacturer Narrative
Qn#(b)(4).The device history record (dhr) review was performed on the reported serial number (b)(4) and there were no issues found related to the complaint.A document assessment (b)(4) was conducted and no changes were required.Customer complaint cannot be confirmed due to the fact the product sample is not available to perform a proper investigation and determine the root cause.If the sample becomes available at a later date, this complaint will be updated accordingly.We will continue to monitor and trend similar complaints.
 
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Brand Name
HUDSON CONCHA NEPTUNE
Type of Device
HEATED HUMIDIFICATION SYSTEM
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer Contact
warrenda peterson
3015 carrington mill blvd.
morrisville, NC 27560
9193613959
MDR Report Key4645208
MDR Text Key18033485
Report Number3003898360-2015-00183
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 Biomedical Engineer
Type of Report Initial
Report Date 02/24/2015
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
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/24/2015
Initial Date FDA Received03/23/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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