BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXI SKY 600

    MDR report key: 21177763 · Received January 17, 2025

    Report

    Report Number
    1419652-2025-00002
    Event Type
    Death
    Date Received
    January 17, 2025
    Date of Event
    December 20, 2024
    Report Date
    January 17, 2025
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    ARJO WAS NOTIFIED OF AN INCIDENT INVOLVING A MAXI SKY 600 CEILING LIFT (B)(6) AND AN ARJO LOOP SLING (B)(6). IT WAS REPORTED THAT A RESIDENT WAS BEING TRANSFERRED FROM A BED TO A WHEELCHAIR WITH THE ASSISTANCE OF 2 CAREGIVERS. AS THE RESIDENT WAS BEING LIFTED OVER THE WHEELCHAIR, THE RESIDENT SLIPPED OUT OF THE SLING AND FELL (HEADFIRST TO THE FLOOR). THE RESIDENT SUSTAINED VISIBLE LACERATION THEREFORE WAS TAKEN TO THE EMERGENCY DEPARTMENT FOR ASSESSMENT. A COMPUTED TOMOGRAPHY SCAN AND AN X-RAY WERE PERFORMED, WHICH SHOWED NO INJURIES. THE RESIDENT RETURNED TO THE FACILITY THE FOLLOWING DAY. THE RESIDENT'S CONDITION DETERIORATED OVERNIGHT AND SHE WAS SENT BACK TO THE EMERGENCY DEPARTMENT. THE MEDICAL DIRECTOR REVIEWED THE RESIDENT'S MEDICAL RECORDS AND REPORTED THAT THE RESIDENT SUSTAINED A RIGHT HIP FRACTURE AND A LEFT DISTAL CLAVICLE FRACTURE. THESE INJURIES HAD NOT BEEN IDENTIFIED AT THE INITIAL EMERGENCY DEPARTMENT VISIT. THE PATIENT SUFFERED A FAT EMBOLISM SYNDROME. THE RESIDENT PASSED AWAY ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017432 MAXI SKY 600 LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Death