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

Model Number	IPN040673
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Ventilator Dependent (2395)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn (b)(4).
Event or Problem 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 or Problem 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".
Additional 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
• Common Device Name: CONDENSER, HEAT AND MOISTURE (
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11934976
• Report Number: 8040412-2021-00157
• Device Sequence Number: 3249632
• Product Code: BYD
• UDI-Device Identifier: 04026704347810
• UDI-Public: 04026704347810
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/28/2025
• Device Model Number: IPN040673
• Device Catalogue Number: 10011
• Device Lot Number: KMH20G0005
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 06/29/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 06/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VENTILATOR; VENTILATOR