MAUDE Adverse Event Report: SALTER LABS DE MEXICO DE S.A. DE C.V. AIRLIFE; AIRLIFE INFANT CUSHION NASAL CANNULA 7 FOOT (2.1 M) CRUSH-RESISTANT OXYGEN TUBIN

Model Number	SFT2601
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Type of Reportable Event	Serious Injury
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced three different incidences, which were associated with separate units, involving three different patients.This is the first of three reports.Refer to 3004748541-2025-00124 for the second report refer to 3004748541-2025-00125 for the third report.Med sun user facility mdr report -(b)(4) reported: infant was desaturating and registered nurse (rn) found that nasal cannula had become disconnected from the humidifier.No one was in the room with the infant; it had apparently fallen off of connector.Rn reconnected the nasal cannula to the humidifier.There were no cracks in the nasal cannula tubing.No harm to the patient.
Additional Manufacturer Narrative
H6: (appropriate term/code not available): the device was reconnected.The actual complaint product was not returned for evaluation; additionally, no photographic/videographic evidence was provided by the reporter.In the absence of a photo or video, the complaint could not confirmed; without a sample to perform functional evaluation, a root cause could not be determined.The device history record for lot 537838 was reviewed and the product was produced according to product specifications.All information reasonably known as of 19 nov 2025 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 sun med holdings llc.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 sun med holdings llc.Sun med holdings llc.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 sun med holdings 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 sun med holdings llc.Product is defective or caused serious injury.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE INFANT CUSHION NASAL CANNULA 7 FOOT (2.1 M) CRUSH-RESISTANT OXYGEN TUBIN
• Manufacturer (Section D): SALTER LABS DE MEXICO DE S.A. DE C.V.; blvd. independencia #2167; parque ind. las americas; horizonte sur. cd. juarez, mx 32596 ; MX 32596
• Manufacturer (Section G): SALTER LABS DE MEXICO DE S.A. DE C.V.; blvd. independencia #2167; parque ind. las americas; horizonte sur. cd. juarez, mx 32596 ; MX 32596
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 23600913
• Report Number: 3004748541-2025-00123
• Device Sequence Number: 18593227
• Product Code: NFB
• UDI-Device Identifier: 10190752117730
• UDI-Public: (01)10190752117730(10)537838(17)300217(11)250217
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SFT2601
• Device Catalogue Number: SFT2601
• Device Lot Number: 537838
• 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: 10/20/2025
• Initial Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 12 DA
• Patient Sex: Male