BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIKING M

    MDR report key: 4862553 · Received June 18, 2015

    Report

    Report Number
    8030916-2015-00085
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT FOUND THAT THE CONTROL BOX HAD NO FUNCTION. 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 CONTROL BOX TO RESOLVE THE ISSUE. BASED ON THE INFO, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    HILL-ROM REC'D A REPORT FROM THE ACCOUNTING STATING THAT THE CONTROL BOX ON THE LIFT HAD A SPARK FROM WHERE THE CHARGING CABLE IS CONNECTED AT THE BOTTOM OF THE CONTROL BOX. NO SMOKE OR FLAMES COULD BE SEEN. 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
    398403 VIKING M NON-AC POWERED PATIENT LIFT FSA LIKO AB 2040015

    Patients

    Seq Age Sex Outcome Treatment
    1