MAUDE Adverse Event Report: AIRLIFE AIRLIFE; AIRLIFE AUTOFILL HUMIDIFICATION CHAMBER

Model Number	AH290
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported; a staff member slipped on the water which was leaking from the edge of the metal at the bottom of the humidifier chamber.There was no reported injury or medical intervention.
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 18 jun 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.
Additional Manufacturer Narrative
Additional information-investigation conclusion: d4; h2; h6.The actual complaint product was not returned for evaluation; additionally, no photographs or videos were provided for review.Without a sample to perform functional evaluation, a root cause could not be determined.Without a photo or video depicting the reported issue the complaint could not be confirmed.The device history record for lot 2m24c21 was reviewed and the product was produced according to product specifications.All information reasonably known as of 24 jul 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, a staff member slipped on the water which was leaking from the edge of the metal at the bottom of the humidifier chamber.There was no reported injury or medical intervention.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE AUTOFILL HUMIDIFICATION CHAMBER
• Manufacturer (Section D): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer (Section G): AIR LIFE; productos urologos de mexico s; no. 85 parque indus. mexicali; mexicali baja california, mx ; MX
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22286411
• Report Number: 1314417-2025-00039
• Device Sequence Number: 21063364
• Product Code: BTT
• UDI-Device Identifier: 10889483595923
• UDI-Public: (01)10889483595923(10)2M24C21(11)240321(17)260320
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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 Expiration Date: 03/20/2026
• Device Model Number: AH290
• Device Catalogue Number: AH290
• Device Lot Number: 2M24C21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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