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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON CONCHATHERM NEPTUNE HEATED HUMIFIER; HEATED HUMIDIFICATION SYSTEM
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TELEFLEX HUDSON CONCHATHERM NEPTUNE HEATED HUMIFIER; HEATED HUMIDIFICATION SYSTEM Back to Search Results
Catalog Number 425-00
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/29/2014
Event Type  malfunction  
Event Description
The complaint is reported as: "the unit was involved in an incident where the patient circuit melted during operation." no patient injury reported.The current condition of the patient is listed as fine.
 
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, however, the evaluation 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 HEATED HUMIFIER
Type of Device
HEATED HUMIDIFICATION SYSTEM
Manufacturer (Section D)
TELEFLEX
research triangle park NC
Manufacturer Contact
katharine tarpley
po box 12600
rtp, NC 27709
9194334854
MDR Report Key4188242
MDR Text Key5091096
Report Number3003898360-2014-00835
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 09/29/2014
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 Manufacturer10/07/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/29/2014
Initial Date FDA Received10/16/2014
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
HUDSON ADULT HEATED WIRE CIRCUIT, INSPIRATORY
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