MAUDE Adverse Event Report: SALTER LABS COMFORT SOFT PLUS; COMFORT SOFT PLUS ADULT CANNULA

Model Number	0567-RC
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
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 20 nov 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: tubing became disconnected at connection site.
Event or Problem Description
It was reported: tubing became disconnected at connection site.
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 20 nov 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 of "tubing became disconnected at connection site" regarding part 0567-rc was not confirmed.The root cause was not determined.A risk assessment was performed, and the ultimate risk was determined to be medium which does not require escalation to the capa review board.There have been 3 other complaints regarding the same part and a similar issue within the 24 months preceding this reported event.A quality control alert was issued.A resolution letter was sent to the customer.Complaints will continue to be monitored for possible trends.Risk assessment the ultimate risk is medium, as that is the highest risk of the patient/caregiver and regulatory/compliance considerations: 1.Patient/caregiver performed risk assessment with rma-20017af rev 1; the most closely associated risk is id r23 (p1=1, p2=1) with a probability of harm occurring p=1 and severity s= 4 critical which is medium risk.The calculated p1 based on complaints and sales in the previous 24 months is 2 (remote).Therefore, the probability of harm occurring (p) remains the same as the rma and is determined to be medium risk per ref-20001-c1 rev2.2.Regulatory/ compliance reviewed ref-20001-c1 rev2, and there is low regulatory/ compliance risk.3.Brand recognition and customer impact reviewed ref-20001-c1 rev2, and there is medium brand recognition/customer impact.

• Brand Name: COMFORT SOFT PLUS
• Common Device Name: COMFORT SOFT PLUS ADULT 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 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 ; 6162598415
• MDR Report Key: 23612387
• Report Number: 3004748541-2025-00127
• Device Sequence Number: 9203468
• Product Code: CAT
• UDI-Device Identifier: 10889483233993
• UDI-Public: (01)10889483233993(10)547989
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2026

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: 0567-RC
• Device Catalogue Number: 0567-RC
• Device Lot Number: 547989
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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