BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLVO 8008 LOWBASE WITH CABLE

    MDR report key: 4862555 · Received June 18, 2015

    Report

    Report Number
    8030916-2015-00081
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 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 CALLED HILL-ROM TECHNICAL SUPPORT TO TROUBLE SHOOT. THE ACCOUNT PLACED AN ORDER FOR A MIDDLE BEAM. THE GEAR RACK IS INCLUDED AS PART OF THE MIDDLE BEAM. 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 WILL REPLACE THE MIDDLE BEAM WITH GEAR RACK SET TO RESOLVE THE ISSUE. BASED ON THIS INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM REC'D A REPORT FROM THE ACCOUNT STATING THAT ONE LEG WILL NOT RETRACT. THE LIFT WAS LOCATED IN THE PT ROOM. THERE WAS NO PT/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
    397202 GOLVO 8008 LOWBASE WITH CABLE NON-AC POWERED PATIENT LIFT FSA LIKO AB P2000039

    Patients

    Seq Age Sex Outcome Treatment
    1