MAUDE Adverse Event Report: SALTER LABS N/A; HIGH FLOW OXYGEN THERAPY KIT

Model Number	79SOFT-7
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	06/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient initially stated that, while wearing oxygen and attempting to wash their face at a bathroom sink, a spark was generated by the hot water, causing the oxygen tubing to ignite and explode.The patient later recanted this account and reported that the incident occurred when a lighter was ignited in close proximity to the oxygen tubing, acknowledging that the lighter was the source of ignition.As a result of the event, the patient was hospitalized and transferred to the intensive care unit (icu) for observation and treatment.The patient sustained first- and second-degree burns to the face, head, and upper chest, as well as nasal congestion, and received wound care treatment and a plastic surgery consultation.
Additional Manufacturer Narrative
Annex g - 4756: appropriate term/code not available - high flow oxygen therapy kit.The complaint product was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 10 july 2026 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 airlife represents all of the information known 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 provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and identified as complaint-14756.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 airlife product was defective or caused serious injury.
Event or Problem Description
It was reported that the patient initially stated that, while wearing oxygen and attempting to wash their face at a bathroom sink, a spark was generated by the hot water, causing the oxygen tubing to ignite and explode.The patient later recanted this account and reported that the incident occurred when a lighter was ignited in close proximity to the oxygen tubing, acknowledging that the lighter was the source of ignition.As a result of the event, the patient was hospitalized and transferred to the intensive care unit (icu) for observation and treatment.The patient sustained first and second degree burns to the face, head, and upper chest, as well as nasal congestion, and received wound care treatment and a plastic surgery consultation.
Additional Manufacturer Narrative
Annex g - 4756: appropriate term/code not available - high flow oxygen therapy kit correction: g4.The complaint product was not returned for evaluation; however, photographic evidence was provided by the reporter.Review of the submitted photos confirmed the reported issue.The investigation determined that the event resulted from user error.A review of complaint history identified no similar complaints involving the same part number and failure mode within the previous 24 months.No additional trends were identified; monitoring will continue for any emerging trends.The device history record for lot 592175 was reviewed, and confirmed that the product was manufactured according to specifications.All information reasonably known as of 13 aug 2026 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 airlife represents all of the information known 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 provided by the user facility where the incident occurred.This product incident is documented in the airlife 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 airlife product was defective or caused serious injury.

• Brand Name: N/A
• Common Device Name: HIGH FLOW OXYGEN THERAPY KIT
• 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; parque ind. las americas cd; juarez, chih, 32575 ; MX 32575
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 25782954
• Report Number: 3004748541-2026-00136
• Device Sequence Number: 9633160
• Product Code: BTT
• UDI-Device Identifier: 00607411915932
• UDI-Public: (01)00607411915932(10)592175(11)260519
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K113542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: 79SOFT-7
• Device Catalogue Number: 79SOFT-7
• Device Lot Number: 592175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2026
• Supplement Date Received by Manufacturer: 07/24/2026
• Initial Report FDA Received Date: 07/10/2026
• Supplement Report FDA Received Date: 08/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2026
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown