MAUDE Adverse Event Report: Happiest Baby, Inc. SNOO Smart Sleeper

Model Number	S1000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Dyspnea (1816); Distress (2329)
Date of Event	04/10/2026
Type of Reportable Event	Serious Injury

• Brand Name: SNOO Smart Sleeper
• Common Device Name: SNOO Smart Sleeper
• Manufacturer (Section D): Happiest Baby, Inc.; 11390 w. olympic blvd; suite 450; los angeles CA 90064
• Manufacturer (Section G): AVC Corporation; 10240 alameda st; south gate CA 90280
• Manufacturer Contact: sameer samant ; 11390 w olympic blvd.; suite 450; los angeles, CA 90064 ; +1(310)476-4440
• MDR Report Key: 50926776
• Report Number: 3030187577-2026-00011
• Device Sequence Number: 21522301
• Product Code: QTG
• UDI-Device Identifier: 00817720020085
• UDI-Public: (01)00817720020085
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: DEN210039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: S1000
• Device Lot Number: 201924
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female