MAUDE Adverse Event Report: SALTER LABS SALTER AIRE ELITE; COMPRESSOR WITH (1) 8900 NEBULIZER

Model Number	8350-8900-7-1
Medical Device Problem Code	Energy Output Problem (1431)
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 was not returned for evaluation.A review of the device history record is in-progress.All information reasonably known as of 18 mar 2026 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 21 cfr 803, 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 five different incidences, which were associated with the same unit, involving the same patient.This is the second of five reports.Refer to 3004748541-2026-00050 for the first report.Refer to 3004748541-2026-00052 for the third report.Refer to 3004748541-2026-00053 for the fourth report.Refer to 3004748541-2026-00054 for the fifth report.It was reported, the at home asthma user has used the salter aire elite compressor approximately five times, and each time they turned it on, the motor started out regular but would immediately slow down to where there was no medicine coming out.They had to turn it on and off about 15 times before it worked at regular speed.There was no report of harm or injury as a result of this reported event.

• Brand Name: SALTER AIRE ELITE
• Common Device Name: COMPRESSOR WITH (1) 8900 NEBULIZER
• Manufacturer (Section D): SALTER LABS; 30 spur dr; el paso TX 79906
• 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: 24634140
• Report Number: 3004748541-2026-00051
• Device Sequence Number: 8688514
• Product Code: CCQ
• UDI-Device Identifier: 00607411918346
• UDI-Public: (01)00607411918346(10)KSN2203-12208(17)280324(11)250324
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

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: Lay User/Patient
• Device Model Number: 8350-8900-7-1
• Device Catalogue Number: 8350-8900-7-1
• Device Lot Number: KSN2203-12208
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/24/2025
• 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: Female