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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON CONFORT FLO HUMIDIFICATION SYSTEM WITH; HUMIDIFIER NEBULIZER KIT
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HUDSON CONFORT FLO HUMIDIFICATION SYSTEM WITH; HUMIDIFIER NEBULIZER KIT Back to Search Results
Model Number IPN913729
Medical Device Problem Code Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 12/13/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be conducted since the lot number of the device was not provided.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.
 
Event or Problem Description
It was reported "that the plastic tubing from the concha column will kink off due to the flimsiness".Unknown patient condition.
 
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Brand Name
HUDSON CONFORT FLO HUMIDIFICATION SYSTEM WITH
Common Device Name
HUMIDIFIER NEBULIZER KIT
MDR Report Key11229671
Report Number3004365956-2021-00014
Device Sequence Number3286006
Product Code OGG
UDI-Device Identifier14026704659354
UDI-Public14026704659354
Combination Product (Y/N)N
Initial Reporter StateNE
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/06/2021
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
Operator of Device No Information
Device Model NumberIPN913729
Device Catalogue Number2414
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/06/2021
Initial Report FDA Received Date01/26/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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