MAUDE Adverse Event Report: WESTMED LLC MASK, ADULT AEROSOL, VENTED

Model Number	0250
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 17 oct 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.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 airlife.Airlife 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 airlife complaint database and is 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 a airlife product is defective or causes serious injury.
Event or Problem Description
It was reported that the front of the piece of the mask where the nebulizer connects to continues to fall off when giving breathing treatments to patients.Respiratory manager stated that she has sent in 5 complaints to her supply chain manager regarding this issue.They have had issues with multiple lot numbers.This sample is a current lot that they have had issues with.Current issue is disrupting workflow as providers are having to go back and fix the mask, put the nebulizer back in, and get more medication due to spilling.Plan to meet with respiratory director and bring samples of other aerosal products.Respiratory manager said she will have samples set to the side.
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 17 oct 2025 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.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 airlife.Airlife 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 airlife complaint database and is identified as complaint (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.The complaint of "the front of the piece of the mask where the nebulizer connects to continues to fall off when giving breathing treatments to patients" regarding part 0250 was not confirmed.The root cause was not determined.A risk assessment was performed, and the ultimate risk was determined to be low which does not require escalation to the capa review board.There was 1 other complaint regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.Risk assessment: the ultimate risk is low, as that is the highest risk of the patient/caregiver and regulatory/compliance considerations: 1.Patient/caregiver performed risk assessment with rma-20013a revision 8; the most closely associated risk is id r23 (p1=1, p2=1) with a probability of harm occurring p=1 and severity s= 3 (serious) which is low risk.The calculated p1 based on complaints and sales in the previous 24 months is 1 (improbable).Therefore, the probability of harm occurring (p) remains the same as the rma and is determined to be low risk per ref-20001-c1 rev2.2.Regulatory/ compliance: reviewed ref-20001-c1 rev2, and there is low regulatory/ compliance risk.3.Brand recognition and customer impact: reviewed ref-20001-c1 rev2, and there is high brand recognition/customer impact.
Event or Problem Description
It was reported that the front of the piece of the mask where the nebulizer connects to continues to fall off when giving breathing treatments to patients.Respiratory manager stated that she has sent in 5 complaints to her supply chain manager regarding this issue.They have had issues with multiple lot numbers.This sample is a current lot that they have had issues with.Current issue is disrupting workflow as providers are having to go back and fix the mask, put the nebulizer back in, and get more medication due to spilling.Plan to meet with respiratory director and bring samples of other aerosal products.Respiratory manager said she will have samples set to the side.

• Brand Name: MASK, ADULT AEROSOL, VENTED
• Common Device Name: MASK, ADULT AEROSOL, VENTED
• Manufacturer (Section D): WESTMED LLC; 5580 s nogales highway; tuscon AZ 85706
• Manufacturer (Section G): WESTMED JAVID DE MEXICO, S.A. DE C.V; carretera internacional km 6.5; edif 18; parque industrial nog; nogales sonora, mexico 84094 ; MX 84094
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 23330971
• Report Number: 2028807-2025-00027
• Device Sequence Number: 9536236
• Product Code: BYG
• UDI-Device Identifier: 00709078003769
• UDI-Public: (01)00709078003769(10)571240
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 0250
• Device Catalogue Number: N/A
• Device Lot Number: 571240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/17/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown