MAUDE Adverse Event Report: SALTER LABS N/A; Percent-O2-Lock® Mask, (Adult). The Percent-O2-Lock® Mask is an air-entrainment

Model Number	8150TG-7-50
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2026
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 09 july 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 the dial at the bottom of the mask to select the percentage of oxygen has been found to continually fall off while in use.
Event or Problem Description
It was reported that the dial at the bottom of the mask to select the percentage of oxygen has been found to continually fall off while in use.
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 09 july 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: the device history record for the part number 8150tg-7-50 with lot number 415976 and udi code (b)(4) was reviewed in order to detect any issue related with the reported defect, the complete lot was manufactured, inspected and released on 31mar2023 per our internal procedures and no issues were found.Device history record (dhr) review: the device history record for the part number 8150tg-7-50 with lot number 514121 and udi code (b)(4) was reviewed in order to detect any issue related with the reported defect, the complete lot was manufactured, inspected and released on 18nov2024 per our internal procedures and no issues were found.Device history record (dhr) review: the device history record for the part number 8150tg-7-50 with lot number nop031918 and udi code (b)(4) was reviewed in order to detect any issue related with the reported defect, the complete lot was manufactured, inspected and released on 23mar2018 per our internal procedures and no issues were found.Risk assessment the ultimate risk is low, as that is the highest risk of the patient / caregiver and regulatory / compliance considerations.Complaint does not need to be escalated to carb.Severity: 3/5, serious, ref-20003-c1, f-h30.1.Patient/caregiver risk impact: there is no applicable risk in a product risk file, so a member of the clinical team was consulted and provided risk id f-h30 with a severity of s = serious (3) and p2 = remote (2) (see attached email).The probability calculated from p1 based on complaints and sales in the previous 24 months (1 complaint(s) / 65,200 units * 100 = 0.0015%) is remote (2), multiplied by p2 from clinical resulting in p = remote (2).By combining p and s, the risk is determined to be low risk (10) per ref-20001-c1 rev 2.2.Regulatory/compliance impact: disconnection is a minor noncompliance therefore is non-violative (low risk).Low risk - incidents that may likely not lead to legal action by a regulatory authority.Complaint history: there have been 0 other complaints for the same issue for part number 8150tg-7-50 in the 24 months prior to the reported complaint.P1 based on complaints and sales in the previous 24 months (1 complaint(s) / 65,200 units * 100 = 0.0015%) is remote.

• Brand Name: N/A
• Common Device Name: Percent-O2-Lock® Mask, (Adult). The Percent-O2-Lock® Mask is an air-entrainment
• 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 ; +1(616)259-8415
• MDR Report Key: 25774238
• Report Number: 3004748541-2026-00133
• Device Sequence Number: 9625170
• Product Code: BYF
• UDI-Device Identifier: 00607411800498
• UDI-Public: (01)00607411800498(10)514121
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/02/2026

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: 8150TG-7-50
• Device Catalogue Number: 8150TG-7-50
• Device Lot Number: 415978, NOP031918, 514121
• 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: 06/09/2026
• Supplement Date Received by Manufacturer: Not provided; 08/03/2026
• Initial Report FDA Received Date: 07/09/2026
• Supplement Report FDA Received Date: 09/03/2026; 09/24/2026
• 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