MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE¿ MISTY MAX WITH PEDIATRIC AEROSOL MASK AND OXYGEN TUBING; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number MASK AEROSOL PED W/MISTY & 7FT TBG 50/CS

Device Problem Fitting Problem (2183)

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

Event Date 12/13/2023

Event Type  Injury  

Event Description

The customer reported that the female end of the ck1001 - mask aerosol ped w/misty & 7ft tbg 50/cs was not able to easily be attached to an oxygen tree, and the flange prevented a few of their compressor units from being used.Staff have been working around this issue by using additional tubing; however, this is leading to waste, which they would prefer to avoid.The patient's impact or harm is currently unknown.

Manufacturer Narrative

H3: 81 other - 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.

Manufacturer Narrative

Based on the investigation and since the customer did send photos of the fg ck1001 with lot number 0004250616 for the investigation, we require the physical sample and/or pictures as evidence to perform a better investigation to confirm the reported defect and determine the cause.In addition, the device history record is reviewed as part of the investigation; however, since the lot number was not provided, the review was not possible.Additionally, a sampling was performed by quality personnel on component female u-connector part number (b)(6) (used for the manufacture of fg ck1001) in inventory by dimensionally inspecting the cavity where it is assembled, finding all inspected samples within specifications.Based on the above, the reported defect was not confirmed, and the root cause was not established.

• Brand Name: AIRLIFE¿ MISTY MAX WITH PEDIATRIC AEROSOL MASK AND OXYGEN TUBING
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north riverwoods blvd; 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18455415
• MDR Text Key: 332203418
• Report Number: 8030673-2024-00369
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K790892
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MASK AEROSOL PED W/MISTY & 7FT TBG 50/CS
• Device Catalogue Number: CK1001
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention