MAUDE Adverse Event Report: VYARIE MEDICAL VYARIE MEDICAL; NEBULIZER WITH AIR ENTRAINMENT

Model Number	002002
Medical Device Problem Codes	Partial Blockage (1065); Complete Blockage (1094); Restricted Flow rate (1248); Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Distress (2329); Irritability (2421)
Date of Event	02/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, the first concentrator shut down and the concentrator and bottle were replaced.The "second concentrator shutdown."through the night another concentrator and bottle [were] replaced, in the morning, yet another one." it was additionally reported, the incident occurred during setup at the patient bedside and the patient exhibited distress and agitation; however, there was no reported injury.
Additional Manufacturer Narrative
The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.All information reasonably known as of 02 may 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sunmed holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sunmed holdings llc.Sunmed holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sunmed holdings llc complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that sunmed holdings llc.Product is defective or caused serious injury.
Additional Manufacturer Narrative
The device history record for lot 000611653 was reviewed and the product was produced according to product specifications.The actual sample, from the reported event was returned and evaluated, no issues were observed on device.The reported failure was not reproduced in the lab during sample evaluation; therefore, the root cause could not be determined and no corrective/preventative actions were initiated.All information reasonably known as of 17 may 2024 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sunmed holdings llc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to sunmed holdings llc.Sunmed holdings llc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the sunmed holdings llc complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that sunmed holdings llc.Product is defective or caused serious injury.
Event or Problem Description
Iit was reported, the first concentrator shut down and the concentrator and bottle were replaced.The "second concentrator shutdown."through the night another concentrator and bottle [were] replaced, in the morning, yet another one." it was additionally reported, the incident occurred during setup at the patient bedside and the patient exhibited distress and agitation; however, there was no reported injury.

• Brand Name: VYARIE MEDICAL
• Common Device Name: NEBULIZER WITH AIR ENTRAINMENT
• Manufacturer (Section D): VYARIE MEDICAL; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali, 21397 ; MX 21397
• Manufacturer (Section G): VYARIE MEDICAL; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544 ; 2054826767
• MDR Report Key: 19326333
• Report Number: 8030673-2024-01005
• Device Sequence Number: 11415065
• Product Code: BTT
• UDI-Device Identifier: 10190752144798
• UDI-Public: 10190752144798
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 002002
• Device Catalogue Number: 002002
• Device Lot Number: 000611653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 04/02/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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