BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3901933 · Received June 30, 2014

    Report

    Report Number
    9616091-2014-01106
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    February 12, 2014
    Report Date
    May 29, 2014
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    DEALER REPORTED THAT THE BASE LEG LEVER ON A (B)(4) PATIENT LIFT WAS LOOSE. THE BASE LEVER WAS TIGHTENED AND SHORTLY AFTER IT BECAME LOOSE AGAIN WHICH CAUSED THE LEGS TO OPEN AND CLOSE ON THEIR OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380485 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVAMEX GRPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other