BEUDAMED
    FDA Adverse Event Death Summary report: N

    SARA STEDY

    MDR report key: 14684141 · Received June 14, 2022

    Report

    Report Number
    1419652-2022-00028
    Event Type
    Death
    Date Received
    June 14, 2022
    Date of Event
    November 23, 2021
    Report Date
    June 14, 2022
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE PATIENT'S RELATIVE REPORTED TO ARJO AN ADVERSE EVENT RELATED TO SARA STEDY ACTIVE FLOOR LIFT. IT WAS REPORTED THAT BEFORE THE EVENT PATIENT HAD A SESSION WITH THE HOSPITAL PHYSIOTHERAPY DEPARTMENT, IT WAS NOTED THAT THE PATIENT WAS UNABLE TO STAND ALONE AND PANICKED WHEN ASKED TO STAND. ON (B)(6) 2021 (EVENING) THE PATIENT¿S RELATIVE RECEIVED A MASSAGE AND PHONE CALL FROM HER MOTHER (PATIENT) WHO WAS TREATED IN THE HOSPITAL. THE INFORMATION RECEIVED INDICATED THAT THE PATIENT FELL DURING THE TRANSFER AND SUSPECTED THAT SUSTAIN A STERNUM FRACTURE. THE PATIENT¿S RELATIVE CONTACTED THE NURSE FROM THE HOSPITAL TO CONFIRM THE INFORMATION RECEIVED. THE NURSE CONFIRMED THAT THE PATIENT FELL DURING TRANSFER TO A BED. THE PATIENT'S RELATIVE STATED THAT THE HOSPITAL PERSONNEL IGNORED HER MOTHER, WHO REPORTED THE PAIN AFTER THE EVENT. ON (B)(6) 2021, THE PATIENT HAD A CT SCAN WHICH CONFIRMED THAT THE PATIENT SUSTAINED A DISPLACED STERNUM FRACTURE. ALSO THE BLOOD TESTING REVEALED THAT THE PATIENT HAD HOSPITAL ACQUIRED ACUTE PNEUMONIA BROUGHT ABOUT BY UNTREATED AND UNVENTILATED INFECTION CAUSED BY THE STERNUM. ON (B)(6) 2021 THE PATIENT PASSED AWAY. THE POST-MORTEM REPORT INDICATED THAT THE CAUSE OF DEATH WAS LINKED TO THE STERNUM FRACTURE FOLLOWING THE DROP. THE COMPLAINT REPORTED STATED THAT THE CASE HAS BEEN PASSED TO THE POLICE. ARJO CONTACTED THE HOSPITAL TO CONFIRM THE ALLEGATION REGARDING THE PATIENT FALLING FROM THE DEVICE. THE HOSPITAL REPRESENTATIVE CONFIRMED THAT ON (B)(6) 2021 THE PATIENT WAS AT (B)(6) HOSPITAL AND INFORMED THAT THERE WERE NO INCIDENTS INVOLVING A PATIENT FALLING FROM EQUIPMENT. AS THE HOSPITAL DENIED THAT ANY ADVERSE EVENT OCCURRED THE DEVICE EVALUATION WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688945 SARA STEDY LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. NTB2000

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Death