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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR; HUMIDIFIER NEBULIZER KIT
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HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR; HUMIDIFIER NEBULIZER KIT Back to Search Results
Catalog Number RHP340U
Device Problem Leak/Splash (1354)
Patient Problem Low Oxygen Saturation (2477)
Event Date 06/24/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "the humidifier adaptor that comes with this product was faulty.It was leaking at the top during use which resulted in having to turn it higher for the patient to be functional".Device was replaced.Unknown patient condition at time of report.
 
Manufacturer Narrative
Qn#(b)(4).Additional information received from customer indicates the patient had a "desaturation around 87%".The customer also reports "we had to go up to 70% fio2 until the problem was discovered and baby was able to maintain 90% on 1/16 of a liter." patient was discharged from the hospital without further complications.In review of reported lot number 21b014 device history record: manufacturing event logs show no issues that may have contributed to the quality issue reported; process parameters were within specification; and qa inspections were acceptable.In review of adaptor lot number 12k20 which was packaged with the reported lot number, manufacturing event logs reported "broken seal gasket", "sleeve station push down cylinder not working", "snap cap jam up (2x)" and "upside down snap cap" which may have caused the issue reported.All issues were corrected, cleared, and restarted; process parameters were within specification; qa inspections were acceptable, and post-sterility and package integrity tests were acceptable.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
 
Event Description
It was reported "the humidifier adaptor that comes with this product was faulty.It was leaking at the top during use which resulted in having to turn it higher for the patient to be functional".Device was replaced.
 
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Brand Name
HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR
Type of Device
HUMIDIFIER NEBULIZER KIT
MDR Report Key12180719
MDR Text Key262159096
Report Number1417411-2021-00015
Device Sequence Number1
Product Code OGG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberRHP340U
Device Lot Number21B014
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Required Intervention;
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