BEUDAMED
    FDA Adverse Event Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 2940063 · Received February 1, 2013

    Report

    Report Number
    9616091-2013-00140
    Date Received
    February 1, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 31, 2013
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2013 "RBS" THE DEALER REPORTED THAT THE (B)(4) PATIENT LIFT CASTER DETACHED DURING A (B)(6) FEMALE PATIENT WAS TRANSFERRED TO A LOUNGE CHAIR, RESULTING IN THE THREE CAREGIVERS BEING SERIOUSLY INJURED BECAUSE THE CASTER LITERALLY UNSCREWED ITSELF. THERE WAS NO PATIENT INJURY REPORTED. SHOULD WE RECEIVE ADDITIONAL INFORMATION, THIS FILE WILL BE REVIEWED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44372 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVAMEX RPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 Other