BEUDAMED
    FDA Adverse Event Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2950814 · Received February 8, 2013

    Report

    Report Number
    1531186-2013-00491
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    February 8, 2013
    Manufacturer
    LAND AMERICA HEALTH & FITNESS
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - TWO MDR REPORTS WILL BE SUBMITTED FOR THIS COMPLAINT, BECAUSE OF DIFFERENT EVENTS AND DATES WERE REPORTED, AND THE FILE NUMBERS ARE THE FOLLOWING: (B)(4).

    Description of Event or Problem · 1

    (B)(4) - IT WAS REPORTED BY THE CONSUMER THAT THE RPL600-1 HYDRAULIC PATIENT LIFT SLING LOOP WAS BROKEN DURING TRANSFER FROM THE BED AND CAUSED HER TO HURT AND BRUISE HER LEG. HOWEVER, NO MEDICAL ATTENTION WAS SOUGHT. ADDITIONALLY, IT WAS REPORTED THAT IN THE PAST THE METAL BAR WHERE THE SLING ATTACHES TO KEPT ON FALLING OUT, AND THE EVENT WAS CAPTURED ON COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54203 NON AC-POWERED PATIENT LIFT 880.5510 FSA LAND AMERICA HEALTH & FITNESS RPL600-1

    Patients

    Seq Age Sex Outcome Treatment
    1 75 Other