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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMIDIFIER,DISPOSABLE; RESPIRATORY GAS HUMIDIFIER
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TELEFLEX MEDICAL HUDSON HUMIDIFIER,DISPOSABLE; RESPIRATORY GAS HUMIDIFIER Back to Search Results
Catalog Number 3230
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/14/2014
Event Type  malfunction  
Manufacturer Narrative
Qn#(b)(4).A visual, dimensional and functional inspection of the device involved in the complaint could not be conducted since the device or a picture of the alleged defect was not provided.A device history record review shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.In order to perform a proper investigation, and determine the source of alleged defect reported, it is necessary to evaluate the sample involved on this complaint.However, material from the production line was verified and no issues were found that can lead this customer complaint.If the device sample becomes available this investigation will be updated with the evaluation results.
 
Event Description
Customer complaint alleges "they installed the humidifier and it is observed that it does not allow to have good contact with the thread of the microflujometer for that reason does not leave oxygen".Alleged issue reported as during functional testing prior to patient use.The device was changed for another one that was "observed to fit normal." no report of patient harm or delay in treatment.
 
Manufacturer Narrative
(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was damage on the thread.Functional testing could not be performed as the sample could not be connected to the flowmeter due to the damage.The customer complaint is confirmed based on the visual inspection of the returned sample.Although the complaint is confirmed , there is not sufficient evidence to confirm the defect originated during the manufacturing process.The root cause for the condition reported could not be identified.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.
 
Event Description
Customer complaint alleges "they installed the humidifier and it is observed that it does not allow to have good contact with the thread of the microflujometer for that reason does not leave oxygen".Alleged issue reported as during functional testing prior to patient use.The device was changed for another one that was "observed to fit normal." no report of patient harm or delay in treatment.
 
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Brand Name
HUDSON HUMIDIFIER,DISPOSABLE
Type of Device
RESPIRATORY GAS HUMIDIFIER
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX   88275
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6597512
MDR Text Key76153842
Report Number3004365956-2017-00228
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeCO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/19/2017
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 No Information
Device Catalogue Number3230
Device Lot Number74G1600893
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/19/2017
Initial Date FDA Received05/30/2017
Supplement Dates Manufacturer Received10/20/2017
Supplement Dates FDA Received10/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
FLOWMETER
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