BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIKING

    MDR report key: 1945955 · Received December 17, 2010

    Report

    Report Number
    8030916-2010-00062
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    June 23, 2010
    Report Date
    June 23, 2010
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS PART OF A RETROSPECTIVE REVIEW IN ACCORDANCE WITH CAPA ACTIVITIES.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT A FACILITY ATTEMPTED A SIDE LIFT WITH A VIKING M LIFT AND IT BENT THE TABS AT THE TOP OF THE MAST. SOMEHOW, THE STAFF POSITIONED THE LEG STRAP OF THE SLING AROUND THE LEG OF THE LIFT. THE PT WAS A LARGER PT BUT WEIGHT IS UNK. WHEN THE STAFF ATTEMPTED TO LIFT THE PT, THE TABS OF THE MAST WERE BENT AS THE LIFT PULLED ITSELF TOGETHER. THE LIFT WAS STOPPED AND THE PT SAFELY LOWERED BACK TO HIS ORIGINAL POSITION. THE PT WAS NOT INJURED. THE LIFT IS NOW FUNCTIONING PROPERLY AND IS BACK IN SERVICE. NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIKING NON-AC POWERED PATIENT LIFT FSA LIKO AB VIKING M

    Patients

    Seq Age Sex Outcome Treatment
    1