MAUDE Adverse Event Report: AIRLIFE AIRLIFE; AIRLIFE HMEF 1000/S WITH FLEXIBLE TUBE, DISPOSABLE

Model Number	557071500
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report was not returned for evaluation, additionally, no photos or videos were provided; the complaint could not be confirmed as reported.The device history record for lot: 0209379 was reviewed and the product was produced according to product specifications.The root cause could not be determined.All information reasonably known as of 10 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 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 an sun med holdings llc.Product is defective or caused serious injury.Fda initial submitted 04apr2025; 2nd ack received: ci250424185717.A1117570528c432685b91263e09b0902.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the second of three reports.Refer to 3010838917-2025-00005 for the first report.Refer to 3010838917-2025-00007 for the third report.It was reported, after the humidity moisture exchange (hme) flex tube was soiled it disconnected from the endotracheal tube (ett) and/or trach, while connected to the in-line ballard suction catheter.It was additionally reported, the nurse and/or respiratory therapist (rt) responded promptly; however, their actions were not specified; there was no reported injury.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE HMEF 1000/S WITH FLEXIBLE TUBE, DISPOSABLE
• Manufacturer (Section D): AIRLIFE; 2710 north ridge dr nw; ste a; grand rapids MI 49544
• Manufacturer (Section G): VYAIRE OY; kuortaneenkatu 2; helsinki, uusimaa FIN-0 0510; FI FIN-00510
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI 49544
• MDR Report Key: 22474723
• Report Number: 3010838917-2025-00006
• Device Sequence Number: 20956983
• Product Code: CAH
• UDI-Device Identifier: 10889483586655
• UDI-Public: (01)10889483586655(17)270409(10)0209379
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K964204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025

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: 557071500
• Device Catalogue Number: 557071500
• Device Lot Number: 0209379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 07/10/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown