BEUDAMED
    FDA Adverse Event Death Summary report: N

    SARA STEDY

    MDR report key: 14684149 · Received June 14, 2022

    Report

    Report Number
    9681684-2022-00040
    Event Type
    Death
    Date Received
    June 14, 2022
    Date of Event
    November 23, 2021
    Report Date
    July 8, 2022
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WAS REPORTED TO ARJO BY A PATIENT¿S DAUGHTER THAT AN ADVERSE EVENT OCCURRED WHILE UTILIZING THE SARA STEDY ACTIVE FLOOR LIFT. IT WAS ALLEGED THAT DURING USE OF THE DEVICE FOR PATIENT HANDLING, THE PATIENT FELL OFF. IT WAS ALSO REPORTED THAT PRIOR TO THE TRANSFER, THE PATIENT HAD BEEN IN A SESSION OF PHYSIOTHERAPY AND WAS NOTED BY THE THERAPIST TO BE UNABLE TO STAND ALONE, AS WELL AS PANICKING WHEN ASKED TO STAND. ON THE EVENING OF (B)(6) 2021, THE PATIENT¿S DAUGHTER RECEIVED A MESSAGE AND PHONE CALL FROM THE PATIENT THAT THE PATIENT HAD FALLEN FROM THE DEVICE AND WAS IN THE HOSPITAL BEING TREATED FOR A FRACTURED STERNUM AS A RESULT OF THE FALL. ACCORDING TO THE PATIENT¿S DAUGHTER SHE THEN CONTACTED THE HOSPITAL TO CONFIRM THE INFORMATION. THE DAUGHTER STATED THAT A NURSE FROM THE HOSPITAL CONFIRMED THE PATIENT HAD FALLEN WHILE BEING TRANSFERRED TO THE BED. THE DAUGHTER ALSO STATES THAT HOSPITAL PERSONNEL IGNORED HER MOTHER WHO HAD REPORTED HAVING PAIN SUBSEQUENT TO THE FALL. ON (B)(6), THE PATIENT HAD A COMPUTERIZED TOMOGRAPHY (CT) SCAN WHICH CONFIRMED THE PATIENT SUSTAINED A DISPLACED STERNAL FRACTURE. BLOOD TESTING REVEALED THAT IN ADDITION TO THE FRACTURE, THE PATIENT HAD ALSO ACQUIRED ACUTE PNEUMONIA MOST LIKELY DUE TO DECREASED VENTILATION RESULTING FROM THE BROKEN STERNUM. ON (B)(6) 2021, THE PATIENT PASSED AWAY. THE POST-MORTEM REPORT INDICATED THAT THE CAUSE OF DEATH WAS LINKED TO A STERNAL FRACTURE AS A RESULT OF THE PATIENT FALLING FROM THE DEVICE. THE COMPLAINANT SUBSEQUENTLY REPORTED THE CASE TO THE LOCAL POLICE DEPARTMENT. AFTER THE ABOVE INFORMATION WAS REPORTED, ARJO CONTACTED THE HOSPITAL TO CONFIRM THE ALLEGATION THAT THE PATIENT FELL FROM THE SARA STEDY. ON (B)(6) 2021, A HOSPITAL REPRESENTATIVE STATED THAT THE PATIENT WAS ADMITTED TO (B)(6) HOSPITAL BUT THAT THERE WERE NO INCIDENTS INVOLVING A PATIENT FALLING FROM ANY EQUIPMENT. SINCE THE HOSPITAL DENIED ANY ADVERSE EVENT OCCURRED, A DEVICE EVALUATION WAS NOT PERFORMED. IN SUMMARY, AND BASED ON THE INFORMATION PROVIDED BY THE PATIENT¿S DAUGHTER, THE PATIENT FELL FROM A SARA STEDY DEVICE. THE HOSPITAL DENIED THAT AN ADVERSE EVENT OCCURRED. DUE TO THE LACK OF SUBSTANTIATED INFORMATION ARJO WAS UNABLE TO IDENTIFY ANY POSSIBLE ROOT CAUSE OF THE ALLEGED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE REGARDING THIS ALLEGATION OR RELATED CIRCUMSTANCES, A FOLLOW UP REPORT WILL BE SUBMITTED. CURRENTLY, THE INCIDENT SCENARIO ALLEGES THAT AN ACTIVE FLOOR LIFT WAS USED FOR PATIENT HANDLING AND DURING USE OF THE DEVICE THE PATIENT FELL, SUSTAINED A SERIOUS INJURY AND SUBSEQUENTLY PASSED AWAY. THERE WAS NO INFORMATION RECEIVED BY ARJO THAT INDICATED A DEVICE MALFUNCTION CAUSED THE PATIENT TO FALL. THIS COMPLAINT IS BEING REPORTED WITH AN ABUNDANCE OF CAUTION DUE TO AN ALLEGATION THAT THE PATIENT FELL, SUSTAINED A SERIOUS INJURY AND SUBSEQUENTLY PASSED AWAY. THERE WAS INFORMATION GIVEN BY THE PATIENT¿S DAUGHTER STATING THERE WAS AN ADVERSE EVENT HOWEVER THE HOSPITAL REPRESENTATIVE DENIED AN ADVERSE EVENT OCCURRED. ACCORDING TO THE PATIENT¿S DAUGHTER, A SARA STEDY ACTIVE FLOOR LIFT WAS USED FOR PATIENT HANDLING AND THE PATIENT FELL FROM THE DEVICE. THE HOSPITAL DID NOT CONFIRM THAT A FALL OCCURRED NOR DID THE HOSPITAL REPORT A DEVICE MALFUNCTION WHICH COULD HAVE CAUSED OR CONTRIBUTED TO A PATIENT FALL, SERIOUS INJURY OR PATIENT DEATH. THEREFORE, ARJO CANNOT DETERMINE ANY RELATIONSHIP BETWEEN THE DEVICE AND THE PATIENT¿S DEATH. THIS COMPLAINT IS BEING REPORTED WITH AN ABUNDANCE OF CAUTION DUE TO THE ALLEGATION RECEIVED FROM THE PATIENT¿S DAUGHTER THAT THE PATIENT FELL FROM A SARA STEDY, SUSTAINED A SERIOUS INJURY AND SUBSEQUENTLY PASSED AWAY.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION PROVIDED TO THE COMPLAINT IS CURRENTLY ANALYZED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON INVESTIGATION CONCLUSION. HOSPITAL DID NOT CONFIRM THAT ADVERSE EVENT OCCURRED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1688953 SARA STEDY LIFT, PATIENT, NON-AC-POWERED FSA ARJOHUNTLEIGH MAGOG INC. NTB2000

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Death