BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3980436 · Received August 5, 2014

    Report

    Report Number
    1525712-2014-04370
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 3, 2014
    Manufacturer
    INVACARE TAYLOR STREET
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    PER PROVIDER AT 10:33AM ON (B)(6) 2014 CUSTOMER CALLED TO REPORT AN INCIDENT THAT ALLEGEDLY INVOLVED THE FOLLOWING PRODUCT OR DEVICE: RELIANT 450 LIFT ON (B)(6) 2014. THE RESIDENT ALLEGEDLY FELL OUT OF THE LIFT. THE RESIDENT USING THE LIFT WAS INJURED, BOTH HIPS WERE FRACTURED. THEY HAD THE RESIDENT ON THE LIFT AS THEY WERE SWIVELING OFF THE BED, AND THE RESIDENT SLID OUT OF THE SLING AS THEY WERE LOWERING HIM ONTO THE FLOOR. DURING THE PROCESS, ONE OF THE LOOPS CAME OFF. THE SLING WAS ATTACHED PROPERLY AND THE CUSTOMER SAID THAT THERE ARE NO SAFETY LATCHES ON THIS PARTICULAR UNIT. NURSES AIDS WERE PRESENT WHEN THE INCIDENT HAPPENS AND TWO RNS AND A LPN WENT TO THE SCENE AFTER IT HAPPENED. RESIDENT IS NOW SEEKING MEDICAL ATTENTION. YES FOLLOW UP REQUESTED. NOT EARLY LIFE OR OUT OF BOX FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457353 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVACARE TAYLOR STREET RPA450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R