BTP-1000S Monitor 100-0045-02Recalls & reported problems

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI B146BTPM0), received between Jul 22, 2022 and Jul 22, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (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.

Most reported problems

Device problems

Biocompatibility1
Patient Device Interaction Problem1
Patient-Device Incompatibility1

Patient problems

Skin Burning Sensation1
Skin Inflammation/ Irritation1

Recent adverse event reports

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

InjuryJul 22, 2022Patient-Device Incompatibility; Biocompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Biocompatibility; Patient Device Interaction Problem
WHEN PATIENT REMOVED DEVICE FOR THE FIRST TIME AS INSTRUCTED, IT IS ALLEGED THAT SHE SUSTAINED INJURIES (BLEEDING AND BURN MARKS).
Patient problems: Skin Burning Sensation; Skin Inflammation/ Irritation
MAUDE report 15089466 ↗

Device details

UDI-DI	`B146BTPM0`
Brand	BTP-1000S Monitor
Model	100-0045-02
Company	Braemar Manufacturing, LLC
Product code	DSI · Detector And Alarm, Arrhythmia
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 25, 2026

Device type (GMDN): Electrocardiographic ambulatory recorder

An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be downloaded and analysed at a medical facility, typically using a computer with a dedicated software. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover).

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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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