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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE; HUMIDIFIER NEBULIZER KIT
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TELEFLEX MEDICAL HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE; HUMIDIFIER NEBULIZER KIT Back to Search Results
Catalog Number 003-40F
Device Problem No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.No device history record review was performed since customer did not provide lot number for defective sample.No sample available from the customer to investigate.Complaint not confirmed.Root cause unknown.If the device becomes available this report will be updated with the evaluation results.
 
Event Description
Customer complaint alleges while performing oxygen therapy with the device "there is no bubbling with a very low flow.We don't known if the baby gets oxygen".Customer reports the patient had a desaturation.The device was changed for a new one.Customer reported the saturation went back to normal.Customer reported there was no medical intervention necessary.Patient condition reported a "fine".
 
Manufacturer Narrative
(b)(4).One 040 humidifier adaptor was received.Visual inspection did not show any issues.The humidifier adaptor was attached to an unused 340 ml water bottle from manufacturing and the trigger was removed.The water bottle/adaptor assembly was attached to an air flow meter.The flow meter was slowly increased to 1 lpm and bubbles were present.The complaint could not be confirmed.
 
Event Description
Customer complaint alleges while performing oxygen therapy with the device "there is no bubbling with a very low flow.We don't known if the baby gets oxygen".Customer reports the patient had a desaturation.The device was changed for a new one.Customer reported the saturation went back to normal.Customer reported there was no medical intervention necessary.Patient condition reported a "fine".
 
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Brand Name
HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE
Type of Device
HUMIDIFIER NEBULIZER KIT
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
900 west university dr.
arlington heights IL 60004
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key7621980
MDR Text Key111850716
Report Number1417411-2018-00045
Device Sequence Number1
Product Code OGG
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number003-40F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/11/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/24/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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