BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXI SKY 2

    MDR report key: 11601292 · Received April 1, 2021

    Report

    Report Number
    1419652-2021-00007
    Event Type
    Death
    Date Received
    April 1, 2021
    Date of Event
    February 26, 2021
    Report Date
    April 1, 2021
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ARJO WAS INFORMED ABOUT THE EVENT INVOLVING MAXI SKY 2 DEVICE AND SLING. IT WAS REPORTED THAT DURING PATIENT'S TRANSFER FROM A TROLLEY TO A CHAIR, THE SLING CAME OFF . THE CAREGIVER CAUGHT THE RESIDENT BEFORE THE FALL BUT THE RESIDENT RECEIVED BLOW TO THE HEAD. AT 11:30 A.M., THE RESIDENT HAS A SEIZURE SIMILAR TO EPILEPSY. THE ALERTED IDE NOTES A SUDDEN DETERIORATION OF THE RESIDENT'S HEALTH AND SHE ALERTED THE EMERGENCY SERVICES. 1:15 PATIENT PASSED AWAY. THERE WAS NO LINK WAS BEING ESTABLISHED BETWEEN THE BLOW TO THE HEAD (AT 9:30 A.M.) AND THE SEIZURE ( AT 11:30 A.M.). AN HEALTH, SAFETY, AND WORKING CONDITIONS COMMITTEE IS PLANNED IN THE NEXT WEEK. NO OTHER INFORMATION IS AVALIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498891 MAXI SKY 2 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Death