BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON AC-POWERED PATIENT LIFT

    MDR report key: 3971015 · Received July 31, 2014

    Report

    Report Number
    9616091-2014-01378
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 26, 2014
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BOLT WOULD NOT TIGHTEN WHERE THE HANDLE FOR BASE IS ON THE (B)(4) LIFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448239 NON AC-POWERED PATIENT LIFT 880.5510 FSA INVAMEX GRPL450-1

    Patients

    Seq Age Sex Outcome Treatment
    1 Other