MAUDE Adverse Event Report: SALTER LABS AIRLIFE; AIRLIFE¿ U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1 M) CRUSH-RESISTANT OXYGEN TUBING

Model Number	001350
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	09/27/2025
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 07 nov 2025 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 a medical device incident (mdi) with harm or with the potential for serious harm/death has been reported.- cardinal health canada product complaint (b)(4).Unknown patient arrived via ems in critical condition following a severe burn injury.Intermittent spo2 challenges including during intubation with manual ventilation via mask, and manual ventilation via ett.Spo2 54% at the lowest.Patient requiring continuous high flow o2 therapy (15lpm via non-rebreather, followed by continuous manual ventilation via mask then ett for 45 minutes, then eventually 100% on ventilator, due to patient's injuries.During this time on 3 occasions, rrts noticed bagger was disconnected from o2 tubing on the bagger side.
Event or Problem Description
It was reported that a medical device incident (mdi) with harm or with the potential for serious harm/death has been reported.- cardinal health canada product complaint pcs251008ioeliy.Unknown patient arrived via ems in critical condition following a severe burn injury.Intermittent spo2 challenges including during intubation with manual ventilation via mask, and manual ventilation via ett.Spo2 54% at the lowest.Patient requiring continuous high flow o2 therapy (15lpm via non-rebreather, followed by continuous manual ventilation via mask then ett for 45 minutes, then eventually 100% on ventilator, due to patient's injuries.During this time on 3 occasions, rrts noticed bagger was disconnected from o2 tubing on the bagger side.
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 07 nov 2025 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.The complaint of "3 occasions, rrts noticed bagger was disconnected from o2 tubing on the bagger side." regarding part 001350 was not confirmed.The root cause was determined to likely be user error.A risk assessment was performed, and the ultimate risk was determined to be medium which does not require escalation to the capa review board.There have been 14 other complaints regarding the same part and a similar issues within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE¿ U/CONNECT-IT OXYGEN TUBING 7 FEET (2.1 M) CRUSH-RESISTANT OXYGEN TUBING
• 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: 23501762
• Report Number: 3004748541-2025-00117
• Device Sequence Number: 8992622
• Product Code: CAT
• UDI-Device Identifier: 10190752116252
• UDI-Public: (01)10190752116252
• 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: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 001350
• Device Catalogue Number: 001350
• 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: 10/08/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 02/03/2026
• 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