BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOR-AM

    MDR report key: 1167666 · Received June 6, 2008

    Report

    Report Number
    1167666
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 20, 2008
    Manufacturer
    NOR-AM PATIENT CARE PRODUCTS
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHILE THE RESIDENT WAS IN A HOYER LIFT, A NOR-AM RL1000, THE SCREW DRIVE ON THE LIFT BROKE AND THE RESIDENT NEEDED TO BE LOWERED TO THE FLOOR. NO INJURIES. ALL NOR-AM LIFTS IN THE FACILITY HAVE BEEN CHECKED FOR MECHANICAL INTEGRITY AND REMAIN IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NOR-AM PATIENT LIFT FNG NOR-AM PATIENT CARE PRODUCTS RL 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other