ePatch 900-0630-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI B146EP010), received between Aug 28, 2019 and Sep 30, 2019 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Electrical Power Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathSep 30, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON 08/28/2019, M.D., DIRECTOR REGIONAL SALES ((B)(6)) RECEIVED A PHONE CALL FROM (B)(6) NOTIFYING OF PATIENT EXPIRY. THE PATIENT WAS IN A NURSING FACILITY (LOCATED IN (B)(6)) AND HAD BEEN WEARING THE WEVENT MONITOR S/N (B)(4) FOR ABOUT THREE (3) DAYS. THE PATIENT WAS FOUND DECEASED OVERNIGHT (FOUND ON (B)(6) 2019) WHILE STILL WEARING THE DEVICE. THE MEDICAL EXAMINER REMOVED THE DEVICE AND THE NURSING STAFF OBTAINED IT FROM THE MORGUE. THE DEVICE WAS RETURNED TO BRAEMAR MANUFACTURING, LLC ON 09/06/2017 UNDER RMA R011745. THE PATIENT CAUSE OF DEATH, IF DETERMINED, IS UNKNOWN TO BRAEMAR MANUFACTURING, LLC AND (B)(6). THIS REPORT IS BEING SUBMITTED DUE TO NOTIFICATION OF PATIENT DEATH WHILE WEARING THE WEVENT MONITOR. THE BECOME AWARE DATE FOR BRAEMAR MANUFACTURING, LLC IS 09/04/2019.

  Patient problems: Sudden Cardiac Death

  MAUDE report 9134509 ↗
• MalfunctionAug 28, 2019Electrical Power Problem; Electrical Power Problem

  ON 08-JUL-2019, THE COMPLAINANT (NON-PATIENT) REPORTED THE FOLLOWING EVENT RELATED TO EPATCH S/N (B)(4): "PLACED A MONITOR ON THE USB TO DOWNLOAD RESULTS NEXT THING I KNOW THERE WAS SMOKE COMING FROM THE MONITOR AND THE CONNECTION PIECE TO THE USB." THE COMPLAINANT INDICATED THAT THEIR COMPUTER WAS NO LONGER FUNCTIONAL AFTER THE EVENT (I.E., AFTER CONNECTING EPATCH TO USB PORT ON THE COMPUTER). THEY INDICATED THAT OTHER DEVICES FROM OTHER MANUFACTURERS WERE NON-FUNCTIONAL ON THE COMPUTER. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. NO DEATH OR INJURY WAS REPORTED AS A RESULT OF THE EVENT. NOTE: BECOME AWARE DATE IS 08/20/2019 BASED ON BECOMING AWARE OF ADDITIONAL INFORMATION FROM BRAEMAR MANUFACTURING, LLC ENGINEERING EVALUATION OF RETURNED DEVICE (EPATCH AND USB CORD). ON 08/20/2019, ENGINEERING WAS ABLE TO USE THE RETURNED USB CORD TO CHARGE THE EPATCH DEVICE AND IT GOT VERY HOT. PATIENT INFORMATION HAS NOT BEEN POPULATED AS THE DEVICE WAS NOT IN USE BY A PATIENT AT THE TIME AND THE COMPLAINT WAS NOT REPORTED BY A PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8941360 ↗