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

Model Number	IPN040673
Medical Device Problem Code	Moisture or Humidity Problem (2986)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "children try to take it off, which is a risk.Customer thinks this item gets wet too easily and that is why children try to take them off by themselves." associated complaints 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00046, 8040412-2025-00045, 8040412-2025-00046, 8040412-2025-00047 and 8040412-2025-00048.
Event or Problem Description
It was reported that: "children try to take it off, which is a risk.Customer thinks this item gets wet too easily and that is why children try to take them off by themselves." associated complaints 8040412-2025-00031, 8040412-2025-00040, 8040412-2025-00041, 80404 12-2025-00042, 8040412-2025-00043, 8040412-2025-00044, 8040412-2025-00046, 8040412-2025-00046, 8040412-2025-00047 and 8040412-2025-00048.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: GIBECK HUMID-VENT MINI
• Common Device Name: CONDENSER, HEAT AND MOISTURE (
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21342238
• Report Number: 8040412-2025-00045
• Device Sequence Number: 8950413
• Product Code: BYD
• UDI-Device Identifier: 04026704347810
• UDI-Public: (01)04026704347810(11)240702(17)260630(10)40H24G0323(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2025

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: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: IPN040673
• Device Catalogue Number: 10011
• Device Lot Number: 40H24G0323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2024
• 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 Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown