BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLVO 7007 ES SANS ACCOUDOIRS

    MDR report key: 5647758 · Received May 11, 2016

    Report

    Report Number
    8030916-2016-00063
    Event Type
    Malfunction
    Date Received
    May 11, 2016
    Date of Event
    April 26, 2016
    Report Date
    April 26, 2016
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THE GEAR RACK OF THE LIFT WAS BROKEN. IN THE SERVICE MANUAL FOR GOLVO 3EN400404, UNDER THE SECTION INSTRUCTIONS REGARDING THE CHECK POINTS, 5B BASE OPENING & CLOSING LINKAGE IT IS STATED: INSPECT GEAR RACK FOR WORN TEETH AND CRACKS WHERE STOP NUT CONTACTS BACK SURFACE. INSPECT FRICTION PLATES. REPLACE IF WORN OR DAMAGED. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS LIFT. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR LIFTS. THE ACCOUNT REPLACED THE GEAR RACK SET TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING ONE LEG CAME OUT ALL THE WAY FROM THEIR PATIENT LIFT. THE LIFT WAS LOCATED IN THE PATIENT AREA AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302432 GOLVO 7007 ES SANS ACCOUDOIRS NON-AC POWERED PATIENT LIFT FSA LIKO AB 2000051

    Patients

    Seq Age Sex Outcome Treatment
    1