MAUDE Adverse Event Report: AIRLIFE AIRLIFE; AIRLIFE¿ ADULT CUSHION NASAL CANNULA WITH FOAM EAR COVERS AND 7 FOOT (2.1 M) CRU

Model Number	FM2699
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Pressure Sore/Ulcer (2326)
Date of Event	06/17/2025
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 18 july 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 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 patient(s) acquired pressure injury from the nasal cannulas.There was no report of medical intervention.Since there were two reports of injury a secondary mdr will be submitted with this one two document both injuries.The first mdr is 1314417-2025-00048.
Event or Problem Description
It was reported that the patient(s) acquired pressure injury from the nasal cannulas.There was no report of medical intervention.Since there were two reports of injury a secondary mdr will be submitted with this one two document both injuries.The first mdr is 1314417-2025-00048.
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 18 july 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 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 the complaint of "2 cases of hospital acquired pressure injury from the nasal cannulas" regarding part fm2699 was not confirmed.The root cause was not determined.A risk assessment was performed, and the ultimate risk was determined to be low which does not require escalation to the capa review board.There have been no other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.Risk assessment: the ultimate risk is low, as that is the highest risk of the patient/caregiver and regulatory/compliance considerations: 1.Patient/caregiver (note: to be used with updated airlife rma files on the 5-point severity scale) performed risk assessment with rma-20017af, revision1; the most closely associated risk is id r115 (p1=1, p2=1) with a probability of harm occurring p=1 and severity s=2 which is low risk.The calculated p1 based on complaints and sales in the previous 24 months is 1.Therefore, the probability of harm occurring (p) remains the same as the rma and is determined to be low risk per (b)(4).Regulatory/ compliance reviewed (b)(4), and there is low regulatory/ compliance risk.

• Brand Name: AIRLIFE
• Common Device Name: AIRLIFE¿ ADULT CUSHION NASAL CANNULA WITH FOAM EAR COVERS AND 7 FOOT (2.1 M) CRU
• Manufacturer (Section D): AIRLIFE; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): AIRLIFE; productos urologos de mexico s; no. 85 parque indust.mexicali; mexicali baja california, mexico 21397 ; MX 21397
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 22549422
• Report Number: 1314417-2025-00049
• Device Sequence Number: 13182034
• Product Code: NFB
• UDI-Device Identifier: 10190752117587
• UDI-Public: (01)10190752117587
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: Health Professional
• Device Model Number: FM2699
• Device Catalogue Number: FM2699
• Device Lot Number: UNKNOWN
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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: Other
• Patient Sex: Unknown