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

Model Number 002003

Device Problem Partial Blockage (1065)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 01/10/2024

Event Type  malfunction  

Event Description

Cannister has problems with the porous stone becoming blocked and the patient not getting flow.Patient not getting flow.

Manufacturer Narrative

There is an interference in therapy and ventilation.

Event Description

Cannister has problems with the porous stone becoming blocked and the patient not getting flow.Patient not getting flow.

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
• Type of Device: 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
• MDR Text Key: 337013847
• Report Number: 8030673-2024-01001
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10190752115200
• UDI-Public: 10190752115200
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/05/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other