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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUATHERM III,ELECTRONIC HEATER; BREATHING SYSTEM HEATER

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TELEFLEX MEDICAL HUDSON AQUATHERM III,ELECTRONIC HEATER; BREATHING SYSTEM HEATER Back to Search Results
Catalog Number 050-14
Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 03/21/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4) product usage when the alleged issue was detected is unknown.The device history record investigation did not show issues related to complaint.A document assessment (fmea) was conducted and no changes required.The sample was returned to the manufacturer, but the investigation is incomplete at the time of this report.
 
Event Description
The customer alleges that the unit failed.No additional specific information given.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and the unit passed all tests except for the current test.It was found that the thermofuse was damaged.Based on the investigation performed, the reported complaint of "unit failed" was confirmed.Although the product showed the defect, a corrective action could not be established due to the fact that all aquatherm heaters are 100% tested at the manufacturing facility; therefore, a defect of this type would be detected prior to release.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not established.
 
Event Description
The customer alleges that the unit failed.No additional specific information given.
 
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Brand Name
HUDSON AQUATHERM III,ELECTRONIC HEATER
Type of Device
BREATHING SYSTEM HEATER
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
rancho el descanso
tecate 21478
MX   21478
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key5573476
MDR Text Key42526286
Report Number3003898360-2016-00320
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 company representative,distri
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number050-14
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received06/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2015
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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