MAUDE Adverse Event Report: SALTER LABS N/A; ADULT. O2/ETCO2 FILTERED ORAL/NASAL DIVIDED CANNULA

Model Number	4MSF1-7-6-25
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the report has not been returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 25 mar 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 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 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 is defective or caused serious injury.
Event or Problem Description
It was reported that there were issues with two of the orange tipped etco2 nasal cannulas.The initial cannula placed on the patient was not functioning.The exact time of placement is unknown, and the lot number and manufacture date for that unit were not available.The primary nurse noted that it had not been working throughout the day.The nurse then replaced it with a new cannula, which stopped functioning after approximately 40 minutes of use.The product was being used at 2 l/min o2 on an afebrile patient.All connections were confirmed to be secure and properly assembled.Airlife received a single report that referenced two different incidents, which were associated with separate units.This is the first of two reports.Refer to 3004748541-2026-00060 for second report.

• Brand Name: N/A
• Common Device Name: ADULT. O2/ETCO2 FILTERED ORAL/NASAL DIVIDED CANNULA
• 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 americas; horizonte s; juarez, 32596 ; MX 32596
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 24695158
• Report Number: 3004748541-2026-00059
• Device Sequence Number: 10151740
• Product Code: CCK
• UDI-Device Identifier: 00607411946363
• UDI-Public: (01)00607411946363(10)579373(11)251110(17)301110
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K151421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2026

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: 4MSF1-7-6-25
• Device Catalogue Number: 4MSF1-7-6-25
• Device Lot Number: 579373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2025
• 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
• Patient Sex: Unknown