BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARINA350EM

    MDR report key: 10843079 · Received November 16, 2020

    Report

    Report Number
    3009481053-2020-00024
    Event Type
    Malfunction
    Date Received
    November 16, 2020
    Date of Event
    November 5, 2020
    Report Date
    April 2, 2021
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW UP CORRECTION IS BEING ISSUED BECAUSE THE INITIAL REPORT WAS INCORRECTLY SUBMITTED UNDER EXEMPTION #E2015025, WHICH WAS REVOKED EFFECTIVE JUNE 30, 2019. THE REQUEST FOR CORRECTION WAS MADE BY (B)(6), MDR PROGRAM EXPERT AT FDA.

    Description of Event or Problem · 0

    LIFT WAS PROVIDED TO DEALER FOR A TRIAL WITH THEIR CLIENT. DEALER SALES REP, OCCUPATIONAL THERAPIST, AND FAMILY WERE PRESENT DURING THE TRIAL. CLIENT WAS LIFTED BY THE EQUIPMENT, SUSPENDED FOR ABOUT 1 MINUTE BEFORE THE BEGUN TO MOVE THEM. ONCE THEY BEGUN TO MOVE THE CARINA, THE CONNECTION POINT BETWEEN THE CLEVIS PIN AND THE BOOM BROKE AND THE CLIENT FELL AND HIT HER HEAD ON THE LEG OF THE FLOOR LIFT. CLIENT'S HEAD BEGAN TO BLEED; SHE WAS ATTENDED TO BY EMS AND HOSPITALIZED FOR 1 DAY.

    Additional Manufacturer Narrative · 1

    HANDICARE USA, THE IMPORTER, NOTIFIED THE MANUFACTURER, HANDICARE AB, OF THE INCIDENT ON (B)(6) 2020. THIS UNIT HAS NOT YET BEEN RETURNED. WHEN RECEIVED, IT WILL BE SENT TO HANDICARE AB FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH THE FINDINGS OF THE INVESTIGATION.

    Description of Event or Problem · 1

    LIFT WAS PROVIDED TO DEALER FOR A TRIAL WITH THEIR CLIENT. DEALER SALES REP, OCCUPATIONAL THERAPIST, AND FAMILY WERE PRESENT DURING THE TRIAL. CLIENT WAS LIFTED BY THE EQUIPMENT, SUSPENDED FOR ABOUT 1 MINUTE BEFORE THEY BEGUN TO MOVE THEM. ONCE THEY BEGUN TO MOVE THE CARINA, THE CONNECTION POINT BETWEEN THE CLEVIS PIN AND THE BOOM BROKE, AND THE CLIENT FELL AND HIT HER HEAD ON THE LEG OF THE FLOOR LIFT. CLIENT'S HEAD BEGAN TO BLEED; SHE WAS ATTENDED TO BY EMS, AND HOSPITALIZED FOR 1 DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312510 CARINA350EM PATIENT LIFT FSA HANDICARE AB 60600011

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization