BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFT,PATIENT,BTTRYPWRD, 450 LB

    MDR report key: 19931927 · Received August 7, 2024

    Report

    Report Number
    1417592-2024-00790
    Event Type
    Death
    Date Received
    August 7, 2024
    Date of Event
    April 16, 2024
    Report Date
    January 16, 2026
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER ON 4/16, "WHILE USING THE MDS450EL TO LIFT A PATIENT, THE SLING LOOP CAME UNHOOKED FROM THE LIFT AND THE PATIENT FELL. THE PATIENT HIT THEIR HEAD. ON (B)(6) 2024, CUSTOMER REPORTED THAT THIS PATIENT DIED FROM THE FALL. THE DEVICE DID NOT MALFUNCTION CAUSING A FALL". IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY REQUIRING MEDICAL INTERVENTION, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATED D4: SERIAL NUMBER: (B)(6). UPDATED D9: RETURNED TO MANUFACTURER: (CHECKED YES). DATE RETURNED TO MANUFACTURER: 7/11/2024. UPDATED H3: YES. UPDATED H6: H6 (B): 10. H6 (C): 213.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER ON 4/16, "WHILE USING THE MDS450EL TO LIFT A PATIENT, THE SLING LOOP CAME UNHOOKED FROM THE LIFT AND THE PATIENT FELL. THE PATIENT HIT THEIR HEAD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546242 LIFT,PATIENT,BTTRYPWRD, 450 LB FSA MEDLINE INDUSTRIES LP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death