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

Device Problem Unexpected Therapeutic Results (1631)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 308947409
• Report Number: 8030673-2023-00297
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10885403006548
• UDI-Public: (01)10885403006548
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/09/2023
• Initial Date FDA Received: 02/06/2023
• 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