MAUDE Adverse Event Report: Salter Labs SALTER; SALTER LABS Full Kit Nebulizer Set with mouthpiece, tee adaptor, reservoir, 7'

Model Number	001350
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	Bradycardia (1751); Low Oxygen Saturation (2477)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury

• Brand Name: SALTER
• Common Device Name: SALTER LABS Full Kit Nebulizer Set with mouthpiece, tee adaptor, reservoir, 7'
• 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: 50940898
• Report Number: 3004748541-2026-00160
• Device Sequence Number: 10749516
• Product Code: CCQ
• UDI-Device Identifier: 10889483570111
• UDI-Public: (01)10889483570111(10)579251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 001350
• Device Lot Number: 579251
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/29/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male