BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXI MOVE

    MDR report key: 11804949 · Received May 11, 2021

    Report

    Report Number
    1419652-2021-00014
    Event Type
    Death
    Date Received
    May 11, 2021
    Report Date
    May 11, 2021
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARJO WAS INFORMED ABOUT THE EVENT INVOLVING MAXI MOVE DEVICE AND SLING. IT WAS REPORTED THAT DURING PATIENT'S TRANSFER A SLING CLIP DETACHED FROM DEVICE SPREADER BAR. AS A CONSEQUENCE OF THE EVENT PATIENT'S HEAD HIT THE CRADLE OF THE LIFT AND THE FOOT BARRIER OF THE BED. ARJO RECEIVED INFORMATION THAT PATIENT PASSED AWAY. THE DEVICE EVALUATION DID NOT REVEAL AND MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700273 MAXI MOVE LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. KMCLAN-D-06

    Patients

    Seq Age Sex Outcome Treatment
    1 Death