BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HML400

    MDR report key: 7821813 · Received August 28, 2018

    Report

    Report Number
    3010605276-2018-00003
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    June 30, 2018
    Report Date
    August 27, 2018
    Manufacturer
    APEX HEALTH CARE MFG., INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOERNS REPRESENTATIVE WENT ON-SITE TO PERFORM A VISUAL INSPECTION ONLY.

    Description of Event or Problem · 1

    WE RECEIVED THE MDR REPORT 3009402404-2018-00048 FROM OUR USA DISTRIBUTOR AND COMPLAINT#(B)(4) WERE ENTERED INTO OUR SYSTEM. THE MDR EVENT ON THE REPORT FROM USA DISTRIBUTOR IS STATED AS BELOW: IT WAS REPORTED TO THE MANUFACTURER BY THE END USER, PER THE END USER, "WE HAD A CUSTOMER USING AN (B)(4), THAT WAS INJURED. (EMT'S CALLED/NO HOSPITAL ADMISSION), WHEN A WELD BROKE ON THE LEG OF THE LIFT DURING A TRANSFER. THE CUSTOMER WEIGHT SHOWS AT 160 POUNDS, SO THEY WERE WELL WITHIN THE WEIGHT CAPACITY." THE PATIENT SUSTAINED A CUT ON THE FOREHEAD AND POSSIBLE BROKEN NOSE. EMT'S CAME TO THE HOME BUT PATIENT REFUSED TO GO TO THE HOSPITAL. (B)(4) WERE ENTERED INTO JOERNS SYSTEM TO HAVE THE LIFT RETURNED TO JOERNS FOR INVESTIGATION. AS OF THIS INITIAL WRITING FROM JOERNS, THE LIFT HAS NOT BEEN RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664119 HML400 MANUAL PATIENT LIFT, PRODUCT CODE: FSA FSA APEX HEALTH CARE MFG., INC. HML400

    Patients

    Seq Age Sex Outcome Treatment
    1