MAUDE Adverse Event Report: VYAIRE MEDICAL GMBH VYAIRE; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number V-892384

Device Problem Insufficient Information (3190)

Patient Problem Cough (4457)

Event Date 09/22/2023

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspected filters have not been returned yet but were requested.Therefore, a definite rot cause has not been determined.Information from the customer and contract manufacturer are gathered to further investigate the issue.At the moment, not enough information are available to come to a final conclusion regarding the risk.It will be updated accordingly once the investigation reveals new information.Vyaire medical will submit a supplemental report if additional information becomes available.H3 other text : device not returned yet.

Event Description

It was reported to vyaire the following involving the microgard filter: the customer complained, that all patients tested on the reported event date kept mentioning that they felt something hitting the back of their throat whenever they did gas transfer.The health professionals (b)(6) decided to test it out by themselves and did their gas transfer a few times using different microgard filters.They found that with most of them, they felt like they were inhaling what they described as "small fibers" like you would do in a dusty environment.It made them cough, gag and choke and they felt the effects of it for the following couple of hours.

• Brand Name: VYAIRE
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): VYAIRE MEDICAL GMBH; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• Manufacturer (Section G): SAINT-GOBAIN PERFORMANCE PLASTICS L&S GMBH; am herrnberg 8; neuhaus 98724 ; GM 98724
• Manufacturer Contact: maren wiese ; leibnizstrasse 7; hoechberg 97204 ; GM 97204
• MDR Report Key: 17954122
• MDR Text Key: 325911524
• Report Number: 9615102-2023-00142
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 34250892903041
• UDI-Public: (01)34250892903041(10)L607788-27(11)230706
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K111408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V-892384
• Device Catalogue Number: V-892384
• Device Lot Number: L 607788-27
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other