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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON FILTER ARIOS; CONDENSER, HEAT AND MOISTURE (
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TELEFLEX MEDICAL SDN. BHD. HUDSON FILTER ARIOS; CONDENSER, HEAT AND MOISTURE ( Back to Search Results
Catalog Number 19211
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that "during the use of the product, it was found that the cap of the filter detached automatically, causing the ventilator to not aspirate.Then changed new one, no impact on patient".No patient harm or injury reported.Patient condition reported as "fine".
 
Manufacturer Narrative
(b)(4).The sample was not returned for evaluation; therefore, 25 pieces of the same product code were selected from current production at the manufacturing facility.The samples were visually inspected and no defects were observed.There were no samples found where the cap could be easily detached.The manufacturer reports in the current manufacturing procedure, 100% leak testing and visual inspection is conducted at the assembly area; therefore, any defective devices would be detected prior to release from the manufacturing facility.A device history record review was performed and no relevant findings were identified.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 "during the use of the product, it was found that the cap of the filter detached automatically, causing the ventilator to not aspirate.Then changed new one, no impact on patient".No patient harm or injury reported.Patient condition reported as "fine.".
 
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Brand Name
HUDSON FILTER ARIOS
Type of Device
CONDENSER, HEAT AND MOISTURE (
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key11710841
MDR Text Key248868028
Report Number8040412-2021-00110
Device Sequence Number1
Product Code BYD
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 04/02/2021
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
Device Operator No Information
Device Catalogue Number19211
Device Lot Number20AT02
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/02/2021
Initial Date FDA Received04/22/2021
Supplement Dates Manufacturer Received05/18/2021
Supplement Dates FDA Received05/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
VENTILATOR; VENTILATOR
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