MAUDE Adverse Event Report: AIRLIFE AIRLIFE; AIRLIFE MISTY MAX 10 NEBULIZER WITH 7 FOOT (2.1 M) FEMALE U/CONNECT-IT CRUSH RES

Model Number	002446
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: (appropriate term/code not available)-4756: medicine dispenser cup.The actual complaint product was not returned for evaluation; additionally, no photographic/videographic evidence was provided by the reporter.In the absence of a photo or video, the complaint could not confirmed; without a sample to perform functional evaluation, a root cause could not be determined.The device history record for lot 0004322107 was reviewed and the product was produced according to product specifications.All information reasonably known as of 03 sep 2025 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings complaint database and identified as (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 an sun med holdings llc.Product is defective or caused serious injury.
Event or Problem Description
It was reported: the paramedic attempted to give the patient a breathing treatment due to shortness of breath (sob) and when she opened the kit, it was missing the med dispenser.There was no reported injury.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE MISTY MAX 10 NEBULIZER WITH 7 FOOT (2.1 M) FEMALE U/CONNECT-IT CRUSH RES
• Manufacturer (Section D): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI
• Manufacturer (Section G): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 22959363
• Report Number: 1314417-2025-00067
• Device Sequence Number: 8453894
• Product Code: CAF
• UDI-Device Identifier: 10889483571170
• UDI-Public: (01)10889483571170(10)0004322107(17)300526(11)50521
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K023602
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/03/2025

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: 002446
• Device Catalogue Number: 002446
• Device Lot Number: 0004322107
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown