MAUDE Adverse Event Report: SALTER LABS SALTER AIRE ELITE; SALTER AIRE ELITE COMPRESSOR WITH NEBULIZER

Model Number	8350-8900-7-1
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 21 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.
Event or Problem Description
It was reported that the nebulizer tubing disconnected, resulting in the patient not receiving the maximum treatment.There was no indication of a delay in therapy or any harm or injury associated with this event.

• Brand Name: SALTER AIRE ELITE
• Common Device Name: SALTER AIRE ELITE COMPRESSOR WITH NEBULIZER
• 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. independence #2167; parque ind. las americas; horizonte sur, ciudad juarez 32596 ; MX 32596
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 23623898
• Report Number: 3004748541-2025-00122
• Device Sequence Number: 10037512
• Product Code: CCQ
• UDI-Device Identifier: 00607411001451
• UDI-Public: (01)00607411001451(11)231122(10)KSN2203-17276
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K870027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 8350-8900-7-1
• Device Catalogue Number: 8350-8900-7-1
• Device Lot Number: KSN2203-17276
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/22/2023
• 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