BEUDAMED
    FDA Adverse Event Death Summary report: N

    MARISA

    MDR report key: 1520232 · Received October 27, 2009

    Report

    Report Number
    9617021-2009-00036
    Event Type
    Death
    Date Received
    October 27, 2009
    Date of Event
    October 1, 2009
    Report Date
    October 4, 2009
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FSA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED, UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE FACILITY REPORTS WHILE TRANSFERRING THE RESIDENT FROM THE BED TO THE WHEELCHAIR, THE SLING BECAME UNHOOKED ON ONE SIDE AND THE RESIDENT FELL TO THE GROUND. THE RESIDENT SUSTAINED AN UNSPECIFIED HEAD INJURY. THE RESIDENT PASSED AWAY THREE DAYS LATER. THE LIFT WAS CHECKED BY THE FACILITY AFTER THE INCIDENT. THE DON WAS NOT AWARE OF ANY SCRATCHES OR DENTS. THE CUSTOMER ALSO INDICATED THE SLING DID NOT SHOW ANY WEAR, TEARS, OR MODIFICATIONS. PER THE CUSTOMER, THE LIFT WAS WORKING TO SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARISA LIFT, PATIENT, NON-AC-POWERED FSA ARJO HOSPITAL EQUIPMENT AB KGA2000

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death