MAUDE Adverse Event Report: Salter Labs N/A; Salter Style Nasal O2 Cannula (Adult), 7' (2.1 m) 0 to 6 LPM, Non DEHP.

Model Number	16SOFT-7-50
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	03/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that several of the item were broken. health deteriorated rapidly because she did not get enough o2.Advice to call in an ambulance but this was not done in the end.Saturation was 70% and the lady was doing very badly.
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 (b)(6) 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 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 several of the item were broken. health deteriorated rapidly because she did not get enough o2.Advice to call in an ambulance but this was not done in the end.Saturation was 70% and the lady was doing very badly.
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 22 april 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 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.Device history record (dhr) review based on the device history record (dhr) review there were no abnormal processing issues noted.All products/packaging were produced per the approved manufacturing procedures, specifications, and inspections.Risk assessment the ultimate risk is low as that is the highest risk of the patient/caregiver and regulatory/compliance considerations: 1.Patient/caregiver performed risk assessment with rma-20017af, revision 2; the most closely associated risk is id r106 (p1= improbable, p2= unlikely) with a probability of harm occurring p= improbable and severity s= negligible which is low risk.The calculated p1 based on complaints and sales in the previous 24 months is improbable (1).Therefore, the probability of harm occurring (p) remains the same as than the rma and is determined to be low risk per ref-20001-c1 rev 2.2.Regulatory/ compliance reviewed ref-20001-c1 rev 2, and there is low regulatory / compliance risk.Complaint history review the complaint history was reviewed in grand avenue from reported dates 03/23/2024 through 03/23/2026, for part number 16soft-7-50 and failure mode "broken cannula".There were 0 (zero) other complaint(s) reported for the same issue and part number during the same timeframe.Sales = 20,916,160 ea calculated occurrence (p1) =( 1 complaint(s) / 20,916,160 ea sold) x 100 = 0.000004% occurrence ranking = improbable (1).

• Brand Name: N/A
• Common Device Name: Salter Style Nasal O2 Cannula (Adult), 7' (2.1 m) 0 to 6 LPM, Non DEHP.
• Manufacturer (Section D): Salter Labs; 30 spur drive; el paso 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 ; +1(616)259-8415
• MDR Report Key: 24961179
• Report Number: 3004748541-2026-00069
• Device Sequence Number: 17391530
• Product Code: CAT
• UDI-Device Identifier: 00607411102318
• UDI-Public: (01)00607411102318(10)548271
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/26/2026

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: 16SOFT-7-50
• Device Catalogue Number: 16SOFT-7-50
• Device Lot Number: 548271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/22/2026
• Supplement Report FDA Received Date: 08/27/2026
• 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