BTP-1000S 900-0634-00Recalls & reported problems
Braemar Manufacturing, LLC · MCOT Holter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B146C6S0), received between Jun 27, 2019 and Aug 8, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
- Patient-Device Incompatibility1
Patient problems
- Burn, Thermal1
- Skin Irritation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 8, 2019Patient-Device Incompatibility
ON (B)(6) 2019, BRAEMAR MANUFACTURING, LLC WAS MADE AWARE OF PATIENT ALLEGATION OF BURN/SKIN REACTION. THE PATIENT ALLEGEDLY WORE A C6 PATCH MONITOR IN EVENT MODE AND INDICATED THAT HER SKIN REACTED ADVERSELY TO THE MONITOR AND THAT SHE EXPERIENCED A SKIN BURN. THE PATIENT INDICATED THAT SHE DID NOT EXPERIENCE AN ADVERSE EVENT WHEN SHE WORE THE FIRST PATCH AND THAT THE EVENT OCCURRED DURING THE SECOND WEEK OF USE.
Patient problems: Burn, Thermal
MAUDE report 8876010 ↗InjuryJun 27, 2019Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem
ON 28-MAY-2019, BRAEMAR MANUFACTURING, LLC WAS MADE AWARE OF PATIENT ALLEGATION OF BURN/SKIN REACTION. THE PATIENT WORE A C6 PATCH MONITOR AND CONTACTED THEIR HEALTHCARE PROFESSIONAL DUE TO AN ALLEGATION OF BLISTERS AND SKIN IRRITATION. THE PATIENT INDICATED TO THEIR HEALTHCARE PROFESSIONAL THAT THE BURN/SKIN IRRITATION IS VERY SERIOUS AND THAT IT IS A THIRD DEGREE BURN. THE HEALTHCARE PROFESSIONAL CONTACTED THEIR ACCOUNT EXECUTIVE CONTACT AND NOTIFIED OF THE EVENT, INDICATING THAT THEY DO NOT BELIEVE THAT THE SKIN IRRITATION/BURN IS SERIOUS. NOTE: THE BECOME AWARE OF THE EVENT FOR LIFEWATCH SERVICES, INC. AND BRAEMAR MANUFACTURING IS 28-MAY-2019, BASED ON NOTIFICATION DATE BY THE INITIAL REPORTER LISTED.
Patient problems: Skin Irritation
MAUDE report 8739022 ↗
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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 13, 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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