BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLVO 8008

    MDR report key: 5230317 · Received November 17, 2015

    Report

    Report Number
    8030916-2015-00140
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    September 15, 2015
    Report Date
    October 22, 2015
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON INVESTIGATION, THE TECHNICIAN NOTED THE RED PLASTIC PART ON THE QUICK-RELEASE HOOK (QRH) WAS BROKEN. ACCORDING TO INSTRUCTION GUIDE (B)(4) REV. 4 "UNIVERSAL SLINGBARS", HILL-ROM STATE WHEN USING A QUICK-RELEASE HOOK SYSTEM, IT SHALL BE CHECKED BEFORE THE SLINGBAR IS IN USE THAT THE QUICK-RELEASE HOOK IS CORRECTLY FASTENED TO THE LIFT AND THE SLINGBAR. 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 TECHNICIAN REPLACED THE QUICK-RELEASE HOOK UNIVERSAL 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 THE SLINGBAR BROKE AWAY FROM THE LIFT BECAUSE THE QUICK-RELEASE HOOK (QRH) WAS BROKEN. THE LIFT WAS LOCATED AT THE ACCOUNT AT THE TIME OF THE INCIDENT. 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
    760930 GOLVO 8008 NON-AC POWERED PATIENT LIFT FSA LIKO AB 2000015

    Patients

    Seq Age Sex Outcome Treatment
    1