BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE

    MDR report key: 7016252 · Received November 9, 2017

    Report

    Report Number
    2438477-2017-00082
    Event Type
    Death
    Date Received
    November 9, 2017
    Date of Event
    October 9, 2017
    Report Date
    October 12, 2017
    Manufacturer
    EMG TECHNOLOGY CO., LTD.
    Product Code
    BTI
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    (B)(4) IS THE INITIAL IMPORTER OF THE DEVICE, WHICH IS A COMPRESSOR. END-USER RENTED THE DEVICE THROUGH A SERVICE PROVIDER. THE END-USER'S DAUGHTER REPORTED THAT THE UNIT OVERHEATED AND SHUT OFF, WHICH IT IS DESIGNED TO DO. THE END-USER DIED THREE DAYS LATER. HER DAUGHTER REPORTED TO THE PROVIDER THAT SHE BELIEVED THE UNIT CAUSED HER MOTHER'S DEATH. HOWEVER, THE DEVICE IS NOT A LIFE-SUSTAINING DEVICE, AND THERE IS NO REPORT OF MALFUNCTION. NO AUTOPSY WAS PERFORMED. IT DOES NOT APPEAR AS THOUGH THERE IS ANY EVIDENCE THAT THE DEVICE CAUSED THE DEATH. DRIVE IS IN POSSESSION OF THE DEVICE, AND IS IN THE PROCESS OF DETERMINING WHETHER TESTING IS NECESSARY. THE DEVICE WILL NOT BE RETURNED INTO CIRCULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795584 DRIVE COMPRESSOR BTI EMG TECHNOLOGY CO., LTD. 18450

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death