MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON HUMID VENT MINI; CONDENSER, HEAT AND MOISTURE (

Model Number IPN040673

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Ventilator Dependent (2395)

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

Qn (b)(4).

Event Description

It was reported that " we have had a family on caseload who has had issues with the humid-vent, they have been using them for a while.They had rang to have more stock as the white filter was falling out so was ineffective".No patient harm or injury reported.Patient condition reported as "fine".

Event Description

It was reported that " we have had a family on caseload who has had issues with the humid-vent, they have been using them for a while.They had rang to have more stock as the white filter was falling out so was ineffective".No patient harm or injury reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the actual sample is not available for return.The manufacturer reports that in the current manufacturing procedure, 100% drop testing is conducted during the assembly process; thus, any defective products would be detected prior to release from the manufacturing facility.It was also reported that ten pieces of the same catalog number were taken from current production at the manufacturing facility to inspect for the reported defect.No visual issues were observed and all ten samples passed drop testing.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.

• Brand Name: HUDSON HUMID VENT MINI
• Type of Device: CONDENSER, HEAT AND MOISTURE (
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11934976
• MDR Text Key: 265437553
• Report Number: 8040412-2021-00157
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 04026704347810
• UDI-Public: 04026704347810
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

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: Lay User/Patient
• Device Model Number: IPN040673
• Device Catalogue Number: 10011
• Device Lot Number: KMH20G0005
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/13/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VENTILATOR; VENTILATOR