MAUDE Adverse Event Report: VYAIRE MEDICAL VYAIRE MEDICAL; CANNISTER HAS PROBLEMS WITH THE POROUS STONE BECOMING BLOCKED AND THE PATIENT NO

Model Number	002003
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Cannister has problems with the porous stone becoming blocked and the patient not getting flow.Patient not getting flow.
Additional Manufacturer Narrative
There is an interference in therapy and ventilation.
Event or Problem Description
Cannister has problems with the porous stone becoming blocked and the patient not getting flow.Patient not getting flow.
Additional Manufacturer Narrative
There is an interference in therapy and ventilation.Based on the investigation and per pictures sent by the customer we can confirm the reported defect.Customer reported that the diffuser "porous stone" part number 65-4197 is blocked.Given that the reported component is purchased from a supplier, the supplier provides us with a certificate certifying that component 65-4197 meets the specified porosity according to our procedures.It's possible that the batch sent by our supplier of component 65-4197 did not have the required porosity for the production of (b)(4), leading to the reported defect."since the reported defect was confirmed the following actions were taken: a quality notification has been sent to our supplier of the component p/n 65-4197.An inspection will be conducted on the next 5 batches of part number 65-4197 arriving at our facility.".

• Brand Name: VYAIRE MEDICAL
• Common Device Name: CANNISTER HAS PROBLEMS WITH THE POROUS STONE BECOMING BLOCKED AND THE PATIENT NO
• Manufacturer (Section D): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer (Section G): VYAIRE MEDICAL; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18843069
• Report Number: 8030673-2024-01001
• Device Sequence Number: 18081970
• Product Code: BTT
• UDI-Device Identifier: 10190752115200
• UDI-Public: 10190752115200
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 002003
• Device Catalogue Number: 002003
• Device Lot Number: 0004169337
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2024
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown