BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIKING M WIRELESS

    MDR report key: 4860058 · Received June 17, 2015

    Report

    Report Number
    8030916-2015-00079
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    May 13, 2015
    Report Date
    May 19, 2015
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON PHOTOS REC'D FROM THE ACCOUNT, IT APPEARS THE SLINGBAR BOLT BROKE DURING THE PT TRANSFER. A SEARCH OF THE HILL-ROM PREVENTATIVE MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTIVE MAINTENANCE ON THIS LIFT. IT IS UNK IF THE FACILITY PERFORMS PREVENTIVE MAINTENANCE ON THEIR LIFTS. NO FURTHER INFO IS AVAILABLE AT THIS TIME. THE INVESTIGATION IS ONGOING, HOWEVER, IF ANY ADD'L RELEVANT INFO IS IDENTIFIED FOLLOWING COMPLETION OF THE INVESTIGATION, THE ADD'L RELEVANT INFO WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    HILL-ROM REC'D A REPORT FROM THE ACCOUNT STATING THAT WHILE LIFTING A PT, THE SLINGBAR FELL OFF THE VIKING M LIFT. THE PT WAS HANGING IN THE LIFT AND FELL FROM APPROXIMATELY 1 M ONTO THE FLOOR, INJURING THEIR LUMBAR VERTEBRA. THE PT WAS TRANSPORTED TO A HOSP. THE PT SUSTAINED A LUMBAR VERTEBRA FRACTURE, WHICH MAY REQUIRE SURGICAL REPAIR. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395480 VIKING M WIRELESS NON-AC POWERED PATIENT LIFT FSA LIKO AB P2040015

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization