MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON HUMID VENT COMPACT S; FILTER, BACTERIAL, BREATHING CIRCUIT

Model Number IPN043766

Device Problem Filtration Problem (2941)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/05/2021

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 daytimes.Patient is fine and was not harmed".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the product was assembled correctly.The manufacturer reports "this issue happen may due to the accumulation of condensation or another device was blocked which connect to this filter.In ifu state that replace unit immediately if there is increasing resistance, if it is soiled with secretion or otherwise obstructed." in the current manufacturing procedure, 100% leak testing and drop test sampling is conducted at the assembly area; 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.Based on the investigation performed, the reported complaint that the filter was blocked could not be confirmed.It was determined that the filter was assembled correctly.

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 05-may-2021 and occurred with 7 filters within 1-2 days.The issue occurred at different daytimes.Patient is fine and was not harmed".

• 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 Key: 11870497
• MDR Text Key: 252183263
• Report Number: 8040412-2021-00150
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 05/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN043766
• Device Catalogue Number: 19401
• Device Lot Number: KMH20L0450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Date Manufacturer Received: 06/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.