MAUDE Adverse Event Report: SALTER LABS N/A; NASAL CANNULA (ADULT) SALTER STYLE WITH 7' (2.1 M) SUPPLY TUBE

Model Number	1600-7-50
Medical Device Problem Codes	Fire (1245); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: cannula 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 jan 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.
Event or Problem Description
It was reported that a patient was smoking during inhalation and burned himself.One incident was reported for this devices.It was stateed that " on (b)(6) 2024 around 9 pm patient inhaled oxygen produced by philips -everflo.Patient smoked during inhalation and burned himself.According to the information he has 2nd degree burns in the head and upper body.His condition was stabilized, and he was hospitalized in the hospital in pilsen.According to the information, the fire brigade was present at the scene.Chief physician referred the patient and agreed with homecare service manager to stop the oxygen treatment.".
Event or Problem Description
It was reported that a patient was smoking during inhalation and burned himself.One incident was reported for this devices.It was stated that "16.12.2024 around 9 pm patient inhaled oxygen produced by philips -everflo.Patient smoked during inhalation and burned himself.According to the information he has 2nd degree burns in the head and upper body.His condition was stabilized, and he was hospitalized in the hospital in pilsen.According to the information, the fire brigade was present at the scene.Chief physician referred the patient and agreed with homecare service manager to stop the oxygen treatment.".
Additional Manufacturer Narrative
H6: cannula.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 jan 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 stated, "16.12.2024 around 9 pm patient inhaled oxygen produced by philips -everflo.Patient smoked during inhalation and burned himself.According to the information he has 2nd degree burns in the head and upper body.His condition was stabilized, and he was hospitalized in the hospital in pilsen.According to the information, the fire brigade was present at the scene.Chief physician referred the patient and agreed with homecare service manager to stop the oxygen treatment." there were, no photo images, physical samples, or videos were provided.The patient sustained second-degree burns to the head and upper body as a result of smoking while receiving oxygen therapy through the nasal cannula, which led to hospitalization.The ifu states not to use o2 while smoking or near an ignition source.This was a user error.A risk assessment was performed, and the ultimate risk was determined to be low which does not require reporting to the capa review board.This is the first complaint reported for part number 1600-7-50, "burn" failure mode.There were 13 complaints reported for part number 1600-7-50 during the same timeframe for other failure modes.A resolution letter was sent to the customer.We will continue to monitor trends during our periodic complaint review meetings.

• Brand Name: N/A
• Common Device Name: NASAL CANNULA (ADULT) SALTER STYLE WITH 7' (2.1 M) SUPPLY TUBE
• Manufacturer (Section D): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer (Section G): SALTER LABS; 30 spur drive; el paso TX 79906
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 21211811
• Report Number: 3000219639-2025-00006
• Device Sequence Number: 11725406
• Product Code: CAT
• UDI-Device Identifier: 10607411100250
• UDI-Public: (01)10607411100250(10)480459
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Consumer,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025

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: Lay User/Patient
• Device Model Number: 1600-7-50
• Device Catalogue Number: 1600-7-50
• Device Lot Number: 480459
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 05/16/2025
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Sex: Unknown