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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON CONCHATHERM NEPTUNE; HEATED HUMIDIFIER
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TELEFLEX HUDSON CONCHATHERM NEPTUNE; HEATED HUMIDIFIER 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 08/17/2014
Event Type  malfunction  
Event Description
The complaint is reported as: "the neptune heater failed.The temperature became high and the heater turned itself off.Staff changed the temperature probe but the problem continued.There was no harm to the patient.".
 
Manufacturer Narrative
A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The product was assembled and inspected according to specifications.The sample was returned for evaluation, however, the investigation was not complete at the time of this report.A follow-up report will be submitted upon completion of the investigation.
 
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Brand Name
HUDSON CONCHATHERM NEPTUNE
Type of Device
HEATED HUMIDIFIER
Manufacturer (Section D)
TELEFLEX
research triangle park NC
Manufacturer Contact
katharine tarpley
po box 12600
rtp, NC 27709
9194334854
MDR Report Key4094961
MDR Text Key4840737
Report Number3003898360-2014-00691
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 Other Health Care Professional
Type of Report Initial
Report Date 08/20/2014
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 Manufacturer08/29/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/20/2014
Initial Date FDA Received09/02/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/01/2009
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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