MAUDE Adverse Event Report: SALTER LABS AIRLIFE; AIRLIFE¿ UNIVERSAL OXYGEN NUT AND NIPPLE CONNECTION

Model Number	001840
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
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 16 jan 2026 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 (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 supplemental oxygen tubing and white connection device disconnected from wall outlet.- chc complaint reference #:(b)(4).
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 16 jan 2026 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 (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.Risk assessment: 1.Patient/caregiver risk impact: performed risk assessment with system hazard analysis from tubing rmf-rc-1300 rev 01; risk associated with having disconnection is risk id tubing-sha-15 with a p1= unanticipated, p2= likely, p= negligible and severity= critical which is medium risk (14).The calculated p1 is based on complaints and sales in the previous 24 months (b)(4) and is unanticipated.Therefore, p= negligible and the overall risk is determined to remain at medium risk (14).2.Regulatory/compliance impact: disconnection is a minor noncompliance therefore is non-violative (low risk).Conclusion: between the 2 risk impacts, while one the risks is medium, occurrence has not gone up, therefore this complaint does not meet the carb escalation criteria.Severity: 4/5, critical, sha for rmf-rc-1300, tubing-sha-15.Device history record (dhr) review: no lot number was reported, and dhr review can't be performed.Complaint history: there have not been other complaints for the same issue for part number 001840 in the 24 months prior to the reported complaint.
Event or Problem Description
It was reported that the supplemental oxygen tubing and white connection device disconnected from wall outlet.- chc complaint reference #: (b)(4).

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE¿ UNIVERSAL OXYGEN NUT AND NIPPLE CONNECTION
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS DE MEXICO DE S.A. DE C.V.; blvd. independencia #2167 parq; ind. las ameri - hor sur cd ju; chihuahua mexico, mexico 32596 ; MX 32596
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 24103954
• Report Number: 3004748541-2026-00008
• Device Sequence Number: 18707070
• Product Code: CAT
• UDI-Device Identifier: 10889483570715
• UDI-Public: (01)10889483570715
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: 001840
• Device Catalogue Number: 001840
• Device Lot Number: UNKNOWN
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown