Night Shift NS27-1005.LERecalls & reported problems

Advanced Brain Monitoring, Inc. · Night Shift LE Device Kit · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850015266195), received between Dec 8, 2025 and Dec 8, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Overheating of Device1
Thermal Decomposition of Device1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 8, 2025Thermal Decomposition of Device; Overheating of Device; Thermal Decomposition of Device; Overheating of Device
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23743303 ↗

Device details

UDI-DI	`00850015266195`
Brand	Night Shift
Model	NS27-1005.LE
Company	Advanced Brain Monitoring, Inc.
Product code	MYB · Pillow,Cervical(For Mild Sleep Apnea)
Class	Class 2
FDA submission	K140190
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 5, 2021

Device type (GMDN): Behavioural therapy electrical stimulation system

An assembly of devices designed to apply harmless but unpleasant electrical impulses to a patient (e.g., in the arm or leg) to modify undesirable behavioural characteristics (e.g., self injurious behaviour). It is typically used for aversion therapy sessions conducted by a therapist and/or in clinical programs at home. Some assemblies include an annoying sound stimulus for sound or sound/electric aversion conditioning. The system is often used in the treatment of obsessive/compulsive behaviour and drug abuse.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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