BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C-SERIES

    MDR report key: 10679881 · Received October 14, 2020

    Report

    Report Number
    3007802293-2020-00003
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    January 20, 2020
    Report Date
    October 14, 2020
    Manufacturer
    HANDICARE USA INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORT WAS SUBMITTED 03FEB20. ON 14OCT20, IT WAS NOTICED THAT THE SUBMISSION WAS NOT SUCCESSFUL. THEREFORE, THE REPORT IS BEING RE-SUBMITTED. INVESTIGATION NARRATIVE: THE NECESSITY OF SLING LOOPS TO BE PROPERLY SEATED IN THE CARRY BAR HOOK PRIOR TO LIFTING AN INDIVIDUAL IS WELL DESCRIBED IN THE USER MANUAL. THE CARRY BAR DID NOT MALFUNCTION. THE USERS WERE RETRAINED.

    Description of Event or Problem · 1

    THE PATIENT WAS PLACED IN THE SLING, AND THE LOOPS OF THE SLING WERE NOT PROPERLY INSTALLED ON THE CARRY BAR, CAUSING THE RESIDENT TO DROP TO THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141764 C-SERIES PATIENT LIFTS FSA HANDICARE USA INC. C-450

    Patients

    Seq Age Sex Outcome Treatment
    1