BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLVO 7007 ES

    MDR report key: 4862536 · Received June 18, 2015

    Report

    Report Number
    8030916-2015-00086
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    June 11, 2015
    Report Date
    June 11, 2015
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THE EMERGENCY STOP WAS NOT FUNCTIONAL AND THE CONTROL BOX WOULD SHOW THAT THE STOP WAS PUSHED IN EVEN WHEN THE STOP WAS PULLED OUT. ACCORDING TO SVC MANUAL, THE EMERGENCY STOP FUNCTION SHALL BE CHECKED AT PERIODIC MAINTENANCE AT LEAST ONCE EVERY YEAR. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS LIFT. IT IS UNK IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR LIFTS. THE ACCOUNT REPLACED THE CONTROL BOX TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THAT AFTER ACTIVATING THE EMERGENCY STOP SWITCH, THE CONTROL BOX WILL NOT READ WHEN IT HAS BEEN DEACTIVATED. THE LIFT WAS LOCATED IN THE PT ROOM 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
    397956 GOLVO 7007 ES NON-AC POWERED PATIENT LIFT FSA LIKO AB 2000010

    Patients

    Seq Age Sex Outcome Treatment
    1