BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPATCH HOLTER DEVICE

    MDR report key: 8941360 · Received August 28, 2019

    Report

    Report Number
    2133409-2019-00009
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    July 8, 2019
    Report Date
    August 20, 2020
    Manufacturer
    BRAEMAR MANUFACTURING, LLC
    Product Code
    DSI
    UDI-DI
    B146EP010
    PMA / PMN Number
    K171410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BRAEMAR MANUFACTURING, LLC HAS COMPLETED A PRELIMINARY EVALUATION OF THE RETURNED DEVICE. BASED ON THE PLASTICS ALIGNMENT, IT WAS DETERMINED THAT THE EMITTED SMOKE OCCURRED WHEN THE USB CORD WAS PLUGGED IN. THIS IS INDICATIVE THAT THE DEVICE WAS UNLIKELY TO BE USED ON THE PATIENT AT THE TIME OF THIS USE CASE. THE USB CORD WAS CONFIRMED TO BE DAMAGED. BRAEMAR ENGINEERING WAS ABLE TO USE THE RETURNED USB CORD TO CHARGE THE EPATCH DEVICE ON A COMPUTER AND THE DEVICE GOT HOT. THE DEVICE WAS NOT IN USE ON THE PATIENT AT THE TIME OF THE EVENT, AS USB CORD USAGE IS LIMITED TO DOWNLOADING DEVICE DATA ONLY. SPECIFIC CIRCUMSTANCES OF COMPUTER AND ELECTRICAL OUTLETS ARE UNKNOWN, AS THIS INFRASTRUCTURE IS LOCATED AT THE CLINIC LOCATION AND CANNOT BE PHYSICALLY VERIFIED BY BRAEMAR MANUFACTURING, LLC. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 0

    ON (B)(6) 2019, THE COMPLAINANT (NON-PATIENT) REPORTED THE FOLLOWING EVENT RELATED TO EPATCH S/N (B)(6): "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). 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.

    Additional Manufacturer Narrative · 1

    BRAEMAR MANUFACTURING, LLC HAS COMPLETED A PRELIMINARY EVALUATION OF THE RETURNED DEVICE. BASED ON THE PLASTICS ALIGNMENT, IT WAS DETERMINED THAT THE EMITTTED SMOKE OCCURRED WHEN THE USB CORD WAS PLUGGED IN. THIS IS INDICATIVE THAT THE DEVICE WAS UNLIKELY TO BE USED ON THE PATIENT AT THE TIME OF THIS USE CASE. THE USB CORD WAS CONFIRMED TO BE DAMAGED. BRAEMAR ENGINEERING WAS ABLE TO USE THE RETURNED USB CORD TO CHARGE THE EPATCH DEVICE ON A COMPUTER AND THE DEVICE GOT VERY HOT. THE DEVICE WAS NOT IN USE ON THE PATIENT AT THE TIME OF THE EVENT, AS USB CORD USAGE IS LIMITED TO DOWNLOADING DEVICE DATA ONLY. SPECIFIC CIRCUMSTANCES OF COMPUTER AND ELECTRICAL OUTLETS ARE UNKNOWN, AS THIS INFRASTRUCTURE IS LOCATED AT THE CLINIC LOCATION AND CANNOT BE PHYSICALLY VERIFIED BY BRAEMAR MANUFACTURING, LLC. NO ADDITIONAL INFORMATION IS KNOWN TO BRAEMAR MANUFACTURING, LLC AT THIS TIME.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736399 EPATCH HOLTER DEVICE EPATCH® HOLTER DEVICE DSI BRAEMAR MANUFACTURING, LLC 900-0630-00 B146EP010

    Patients

    Seq Age Sex Outcome Treatment
    1