MAUDE Adverse Event Report: WESTMED LLC MCKESSON; NEBULIZER KIT, "T" PIECE, MOUTHPIECE 6"

Model Number	32642
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: 4756 (appropriate term/code not available): nebulizer.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 10 dec 2024 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 unit was not working and overheated the nebulizer machine.
Event or Problem Description
It was reported that the unit was not working and overheated the nebulizer machine.
Additional Manufacturer Narrative
H6: 4756 (appropriate term/code not available): nebulizer 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 (b)(6) 2024 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.The reported complaint stated that the unit was not functioning and overheated the nebulizer machine.There was no patient impact.Additionally, no video evidence was provided, preventing confirmation of the issue.However, several factors could contribute to the unit malfunctioning or overheating.Extended operation without breaks may cause the motor to overheat.Dust or debris obstructing airflow can also lead to overheating, and improper cleaning may result in residue buildup, forcing the unit to overwork.Per the risk assessment performed in the activity log, the patient and regulatory risk determination (low) indicates that the complaint does not need to be submitted to carb.This is the first (1) complaint reported for part number 32642, for "overheating" failure mode.There were nine (9) complaints reported for part number 32642 during the same timeframe for other failure modes.A resolution letter was sent to the customer.We will continue to monitor trends during our periodic complaint review meetings.

• Brand Name: MCKESSON
• Common Device Name: NEBULIZER KIT, "T" PIECE, MOUTHPIECE 6"
• 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: 20897852
• Report Number: 2028807-2024-00080
• Device Sequence Number: 5052450
• Product Code: CAF
• UDI-Device Identifier: 20612479203376
• UDI-Public: (01)20612479203376(10)461368
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K926055
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 32642
• Device Catalogue Number: 32642
• Device Lot Number: 461368
• 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: 11/25/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 02/20/2025
• 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