MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE¿ MISTY MAX 10¿ NEBULIZER WITH 7 FOOT (2.1 M) CRUSH RESISTANT OXYGEN TUBI; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	MM10 SVN W/ADULT MASK & 7FT TBG 50/CS
Medical Device Problem Code	Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the 2433 - mm10 svn w/adult mask & 7ft tbg 50/cs doesn't work; it doesn't mist the medication.This happened twice in the icu (intensive care unit).The customer confirmed that there was no patient harm/injury associated with the reported event.

• Brand Name: AIRLIFE¿ MISTY MAX 10¿ NEBULIZER WITH 7 FOOT (2.1 M) CRUSH RESISTANT OXYGEN TUBI
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd me; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16306002
• Report Number: 8030673-2023-00297
• Device Sequence Number: 6185261
• Product Code: CAF
• UDI-Device Identifier: 10885403006548
• UDI-Public: (01)10885403006548
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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: MM10 SVN W/ADULT MASK & 7FT TBG 50/CS
• Device Catalogue Number: 002433
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 02/06/2023
• 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
• Patient Sex: Unknown