BEUDAMED
    FDA Adverse Event Death Summary report: N

    DRIVE MEDICAL

    MDR report key: 4440005 · Received January 20, 2015

    Report

    Report Number
    2438477-2015-00005
    Event Type
    Death
    Date Received
    January 20, 2015
    Date of Event
    January 1, 2014
    Report Date
    December 18, 2014
    Manufacturer
    SHENYANG HENYI ENTERPRISE CO. LTD
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DRIVE MEDICAL RECEIVED NOTIFICATION FROM A SALES REP OF AN ADVERSE INCIDENT REGARDING A PT LIFT THAT DRIVE MEDICAL IMPORTS AND DISTRIBUTES AND CONTACTED THE CUSTOMER IN QUESTION TO GATHER MORE INFO. CUSTOMER INFORMED DRIVE MEDICAL THAT AN INCIDENT OCCURRED AT THE HOME OF AN ENDUSER WHERE THE HOME HEALTHCARE AGENT WAS TAKING CARE OF THE ENDUSER AND ENDUSER WAS ALLEGEDLY DROPPED AND BROKE HIS NECK. DRIVE MEDICAL RECOMMENDS IN ITS PRODUCT MANUAL THAT TWO ATTENDANTS BE PRESENT TO TRANSFER A PT ONTO LIFT, BUT ONLY ONE HOME HEALTHCARE AGENT WAS REPORTED PRESENT BY THE CUSTOMER. CUSTOMER WAS INFORMED BY THE ENDUSER'S WIFE THAT ENDUSER PASSED AWAY. NO OTHER INFO WAS ABLE TO BE GATHERED FROM THE CUSTOMER AND NO MEDICAL RECORDS WERE PROVIDED BY THE CUSTOMER. THE UNIT WAS RETURNED TO DRIVE MEDICAL FOR AN INSPECTION. THIS REPORT IS BASED ON INFO PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46555 DRIVE MEDICAL MANUAL PATIENT LIFT FSA SHENYANG HENYI ENTERPRISE CO. LTD 13023SV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death