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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON HUMID VENT COMPACT S; FILTER, BACTERIAL, BREATHING CIRCUIT
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TELEFLEX MEDICAL SDN. BHD. HUDSON HUMID VENT COMPACT S; FILTER, BACTERIAL, BREATHING CIRCUIT Back to Search Results
Model Number IPN043766
Device Problem Filtration Problem (2941)
Patient Problem Low Oxygen Saturation (2477)
Event Date 05/07/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that "seven hme filters were blocked within shortest time and no oxygen got through.The patient got shortness of breath and had to be supplied with oxygen by an ambubag.This started on (b)(6) 2021 and occurred with 7 filters within 1-2 days.The issue occurred at different daytime's.Patient is fine and was not harmed".
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.In the current manufacturing procedure, 100% drop test sampling is conducted; thus, any defective product would be detected prior to release.The manufacturing facility also reports that ten pieces of the same catalog number in current production were taken to test the reported defect.All ten pieces passed visual examination and functional testing.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 Description
It was reported that "seven hme filters were blocked within shortest time and no oxygen got through.The patient got shortness of breath and had to be supplied with oxygen by an ambubag.This started on (b)(6) 2021 and occurred with 7 filters within 1-2 days.The issue occurred at different daytimes.Patient is fine and was not harmed".
 
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Brand Name
HUDSON HUMID VENT COMPACT S
Type of Device
FILTER, BACTERIAL, BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key11870501
MDR Text Key253544813
Report Number8040412-2021-00153
Device Sequence Number1
Product Code CAH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIPN043766
Device Catalogue Number19401
Device Lot NumberKMH20L0450
Was Device Available for Evaluation? No
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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