MAUDE Adverse Event Report: ADVANCED BRAIN MONITORING, INC. NIGHT SHIFT SLEEP POSITIONER

Model Number	NS27-1005.LE
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported that the night shift device was burning while charging, and that the charging cable connector melted/fused to the charging port on the device.The user reported that there was no injury caused by the incident.Visual inspection of the device found that the enclosure plastic around the charging port was warped and a portion of the usb-c connector of the charging cable was fused to the charging port.Thermal damage was found on the pcb, localized around the usb charging port.The internal battery was intact but had expanded slightly due to heat.The melted charging cable connector could not be removed from the charging port to inspect the inside of the port for debris/corrosion, but the incident is consistent with the types of thermal incidents associated with usb-c connectors when contamination, moisture, or metallic debris causes an electrical short during charging.The user stated that the device was charged in a bathroom using the original charging cable plugged into a multiport usb fast charger.The user was unable to provide the remaining portion of the charging cable for investigation.The exact cause of the incident could not be determined.

• Brand Name: NIGHT SHIFT SLEEP POSITIONER
• Common Device Name: NIGHT SHIFT
• Manufacturer (Section D): ADVANCED BRAIN MONITORING, INC.; 2237 faraday avenue; suite 100; carlsbad CA 92008 7240
• Manufacturer (Section G): ADVANCED BRAIN MONITORING, INC.; 2237 faraday avenue; suite 100; carlsbad CA 92008 7240
• Manufacturer Contact: nolan case ; 2237 faraday avenue; suite 100; carlsbad, CA 92008-7240
• MDR Report Key: 23743303
• Report Number: 3004964738-2025-00001
• Device Sequence Number: 18679629
• Product Code: MYB
• UDI-Device Identifier: 00850015266195
• UDI-Public: (01)00850015266195
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140190
• 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
• Report Date (Section B): 12/05/2025

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: Lay User/Patient
• Device Model Number: NS27-1005.LE
• Device Catalogue Number: NS27-1005.LE
• Device Lot Number: 2301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 77 YR
• Patient Sex: Male