BTP-1000M 02-01548Recalls & reported problems
Braemar Manufacturing, LLC · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI B146C6M50), received between Mar 17, 2022 and May 7, 2024 — classified as 1 death, 2 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (2 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Overheating of Device2
- Difficult to Remove1
- Melted1
- Patient Data Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Cardiac Arrest1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2024Melted; Overheating of Device; Melted; Overheating of Device
IT WAS REPORTED THAT ON (B)(6) 2024, IN THE EARLY MORNING THE PATIENT HAD PLUGGED THEIR MCOT MONITOR INTO THE CHARGER TO CHARGE. ABOUT 15 MINUTES LATER THE PATIENT WNET BACK TO CHECK ON THE MONITOR AND NOTICED IT WAS HOT TO THE TOUCH. IT APPEARED THAT THE USB CHARGING CORD HAD MELTED INTO THE MONITOR. THE PATIENT UNPLUGGED THE MONITOR FROM THE WALL OUTLET AND PACKED THE KIT UP. A REPLACEMENT KIT WAS ORDERED. THERE WAS NO PROPERTY DAMAGE OR PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19264250 ↗MalfunctionFeb 27, 2024Overheating of Device; Difficult to Remove; Overheating of Device; Difficult to Remove
ON (B)(6) 2024 THE PATIENT CALLED REPORTING THAT CHARGING CORD IS STUCK IN THE MONITOR AND THE MONITOR WAS HOT TO THE TOUCH. THE PATIENT WAS INSTRUCTED TO POWER OFF THE MONITOR AND RETURN IT. A REPLACEMENT WAS ORDER. NO HARM TO THE PATIENT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18793573 ↗DeathMar 17, 2022Patient Data Problem; Patient Data Problem
COMPLAINANT ALLEGED THAT THE MCOT SYSTEM WAS NOT RECORDING CRITICAL EVENTS AND/OR NOTIFYING HIS MEDICAL PROFESSIONALS OF CRITICAL EVENTS.
Patient problems: Cardiac Arrest
MAUDE report 13792950 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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