MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE MISTY MAX 10 NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	AIRLIFE MISTY MAX 10 NEBULIZER
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the airlife misty max 10¿ nebulizer are often defective.According to customer they have to open the unit and replace the blue inner piece.There is a risk of contamination during this manipulation and often it does not work anymore.Additionally, the treatment can last up to 40 minutes, when it should usually take 5-10 minutes.The customer confirmed that there was no patient harm associated with the reported event.
Additional Manufacturer Narrative
Device evaluation: d10, g4, g7, h2, h3 and h10.H10: customer sent 10 opened and decontaminated samples which were evaluated and no problems were found.In addition molded components from customer submitted samples were dimensionally inspected and no issues were found.However during the dhr investigation it was found a ncmr 19-2862 in the sub-assembly 65-4424a ( misty max 10 jet), this ncmr was generated since a pin was broken in the mold cavity 30, therefore the defect reported by the customer could be confirmed.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Result of investigation: the device history record (dhr) review did not show any deviations to manufacturer specification.For functionality failure, it is imperative to receive a sample to duplicate the failure as described.

• Brand Name: AIRLIFE MISTY MAX 10 NEBULIZER
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10299420
• Report Number: 8030673-2020-00104
• Device Sequence Number: 19697636
• Product Code: CAF
• UDI-Device Identifier: 10190752116788
• UDI-Public: (01)10190752116788(10)0004115361
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE MISTY MAX 10 NEBULIZER
• Device Catalogue Number: 002430
• Device Lot Number: 0004115361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/16/2020; 10/08/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/12/2020; 11/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1