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

Model Number	0568
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2025
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 jul 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.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 3004748541-2025-00039 for the second report it was reported, the oxygen (o2) tubing was bent at water bottle, it had to be replaced due to the patient not getting o2; the therapist said the tubing is a lot thinner.The device was replaced; there was no reported injury.
Event or Problem Description
Sunmed holdings llc.Received a single report that referenced two different incidences, which were associated with separate units, involving two different patients.This is the first of two reports.Refer to 3004748541-2025-00039 for the second report.It was reported, the oxygen (o2) tubing was bent at water bottle, it had to be replaced due to the patient not getting o2; the therapist said the tubing is a lot thinner.The device was replaced; there was no reported injury.
Additional Manufacturer Narrative
Correction: d4 additional information-investigation conclusion: d4; h2; h6.The actual complaint product was not returned for evaluation; however, the reporter provided photographic/videographic evidence; analysis of the photographic evidence confirmed the complaint as reported.The device history record for lot 546367 was reviewed and the product was produced according to product specifications.All information reasonably known as of 16 sep 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: COMFORT SOFT PLUS
• Common Device Name: COMFORT SOFT PLUS CANNULA
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso TX
• Manufacturer (Section G): SALTER LABS; 30 spur dr; el paso TX
• Manufacturer Contact: racheal cooper ; 2710 north ridge dr nw; ste a; grand rapids, MI
• MDR Report Key: 22614804
• Report Number: 3004748541-2025-00038
• Device Sequence Number: 21233425
• Product Code: CAT
• UDI-Device Identifier: 10889483228982
• UDI-Public: (01)10889483228982(10)546367(17)300324(11)250324
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 09/16/2025

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: 0568
• Device Lot Number: 546367
• 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: 06/27/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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 Sex: Unknown