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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 301 SW,340 ML,JAPAN; RESPIRATORY GAS HUMIDIFIER
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TELEFLEX MEDICAL HUDSON AQUAPAK 301 SW,340 ML,JAPAN; RESPIRATORY GAS HUMIDIFIER Back to Search Results
Catalog Number 003-01J
Device Problems Burst Container or Vessel (1074); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/09/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A visual, dimensional, and functional inspection of the device involved in this 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 device involved.Complaint not confirmed based on the information received.Root cause unknown.If the device is returned at a later date, this report will be updated.Teleflex will continue to monitor feedback from the customers on issues related to bottle inflated excessively with water bottle products.
 
Event Description
Customer complaint alleges " during use, the bottle inflated excessively and blew up.Therefore, the bottle was replaced by a new one and there was no health injury happened." patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).Visual inspection of the plastic 340ml water bottle received, shows the right side panel is stretched and has a large crack.Water bottle left side panel shows stretch but no opening.Trigger opening shows no occlusion and the adaptor port area is properly punctured.040 adaptor received did not show any issues.For functional testing, the adaptor was assembled to the water bottle and attached to a flow meter which then was set at 5 and 10 lpm.Air flow was felt through the diffusers located on the inside bottom of the bottle, and through the trigger opening of the bottle.Bottle was removed leaving the adaptor attached to the flow meter.Flow meter was set at 5 and 10 lpm and the air flow was blocked with a finger to simulate blockage.Whistle and vent worked as intended.A device history record review shows no issues that may have contributed to any quality issues reported in this complaint.Damage was observed to the bottle, but cannot be attributed to any manufacturing defects.The adaptor device functioned as intended during testing.Damage occurred during use.There may have been blockage with the tubing attached to the bottle or the trigger may not have been removed prior to use.
 
Event Description
Customer complaint alleges " during use, the bottle inflated excessively and blew up.Therefore, the bottle was replaced by a new one and there was no health injury happened." patient condition reported as "fine".
 
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Brand Name
HUDSON AQUAPAK 301 SW,340 ML,JAPAN
Type of Device
RESPIRATORY GAS HUMIDIFIER
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
Manufacturer (Section G)
TELEFLEX MEDICAL
900 west university dr.
arlington heights IL 60004
Manufacturer Contact
linda woodall
3015 carrington mill blvd
morrisville 27560
9196942566
MDR Report Key6659527
MDR Text Key78132651
Report Number1417411-2017-00029
Device Sequence Number1
Product Code BTT
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/12/2017
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 Expiration Date06/30/2020
Device Catalogue Number003-01J
Device Lot Number321167
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/14/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/12/2017
Initial Date FDA Received06/22/2017
Supplement Dates Manufacturer Received08/11/2017
Supplement Dates FDA Received08/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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