BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSTAND EVOLV

    MDR report key: 11197117 · Received January 19, 2021

    Report

    Report Number
    2183634-2021-00001
    Event Type
    Injury
    Date Received
    January 19, 2021
    Date of Event
    December 7, 2020
    Report Date
    December 21, 2020
    Manufacturer
    ALTIMATE MEDICAL INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AMI WAS MADE AWARE OF AN INCIDENT IN (B)(6) BY OUR DISTRIBUTOR ANATOMIC SITT WHERE A CAREGIVER WAS UNABLE TO RETURN A UNIT TO THE SEATED POSITION AT THE END OF A CLIENT'S STANDING SESSION AND THAT AN INCIDENT REPORT WOULD NEED TO BE FILED. THE INITIAL REPORT WAS SENT IN (B)(6) FROM THE PATIENTS FACILITY TO THE DISTRIBUTOR AND (B)(6) WAS USED TO TRANSLATE THE REPORT. FROM THE TRANSLATED REPORT, WHILE THE PATIENT WAS STANDING THE PATIENT HAD A DROP IN BLOOD PRESSURE. THE PATIENT WAS REMOVED FROM THE STANDING FRAME AND PLACED IN THEIR WHEELCHAIR. THE PATIENT QUICKLY REGAINED CONSCIOUSNESS AFTER THEIR FEET WERE ELEVATED. THE PATIENT SAID THAT THEY WERE FEELING WELL WHEN THEY WERE HELPED TO THEIR BED AFTER THE INCIDENT. THE CAREGIVER SAYS THE LOWERING FUNCTION OF THE STANDING SUPPORT DID NOT WORK AND WOULD NOT LOWER THE PATIENT TO THE SEATED POSITION. THE PATIENT HAS MULTIPLE SCLEROSIS AND IS PRESCRIBED TO STAND FOR 15 MINUTES HOWEVER, IN THIS SITUATION THE PATIENT WAS STANDING FOR 30 MINUTES. THE PATIENT HAS BEEN USING THE STANDING FRAME WITH THE CAREGIVER APPROXIMATELY 3 TO 5 TIMES A WEEK SINCE THE STANDING FRAME WAS DELIVERED IN FEBRUARY. THE CAREGIVER HAS RECEIVED WRITTEN INSTRUCTION FROM THE PHYSIOTHERAPIST IN REGARDS TO THE STANDING FRAME. THE STANDING FRAME WAS RETURNED TO AMI FOR INSPECTION. THE UNIT WAS RETURNED TO AMI LOWERED INTO THE SEATED POSITION. AFTER REVIEW OF THE STANDING FRAME, THERE WERE NO ISSUES FOUND. THE STANDING FRAME WAS FOUND TO ELEVATE TO THE STANDING POSITION AND RETURN TO THE SEATED POSITION WITHOUT ANY MALFUNCTION. THIS PROCESS WAS COMPLETED MULTIPLE TIMES WITH A PERSON IN THE STANDING FRAME AND WITHOUT ANYONE IN THE STANDING FRAME. THIS WAS ALSO COMPLETED MULTIPLE TIMES WITH AN OCCUPANT LEANING FORWARD IN THE UNIT AS TO NOT APPLY PRESSURE TO THE SEAT AND THE UNIT WOULD PROPERLY RETURN TO THE SEATED POSITION WHEN THE OPERATOR PUSHED BACK ON THE PUMP HANDLE WHILE ALSO APPLYING PRESSURE TO THE SEAT. PAGE 39 OF THE OWNER'S MANUAL OUTLINES THE STEPS TO TAKE IF THE EASYSTAND WILL NOT RELEASE PROPERLY FROM THE STANDING TO SEATED POSITION. "WEIGHT ON THE SEAT IS NEEDED FOR THE UNIT TO DESCEND PROPERLY; IF THE UNIT IS UNOCCUPIED OR THE USER IS LEANING FORWARD AND NOT ENOUGH WEIGHT IS DISTRIBUTED ON THE SEAT, APPLY PRESSURE BY HAND TO THE BACK OF THE SEAT WHILE PUSHING BACK ON THE PUMP HANDLE."

    Description of Event or Problem · 1

    INCIDENT: AFTER A PHONE CALL TO SG: THE UNDERSIGNED GOES DIRECTLY TO THE PATIENT TO REVIEW THE STANDING SUPPORT. THE PATIENT GETS A DROP IN BLOOD PRESSURE WHEN THE UNDERSIGNED TRIES TO LOWER THE STANDING SUPPORT. THE UNDERSIGNED QUICKLY LOOSENS AND MOVES THE PATIENT TO A WHEELCHAIR WITH THE HELP OF A DELEGATE. THE PATIENT QUICKLY REGAINS CONSCIOUSNESS AFTER ELEVATION OF THE FEET. THE PATIENT IS HELPED TO BED AND STATES THAT HE IS FEELING WELL. PROBLEM: TELEPHONE CALLS FROM DELEGATES. THE LOWERING FUNCTION ON THE STANDING SUPPORT DOES NOT WORK AND THE PATIENT DOES NOT GET INTO A SITTING POSITION. THE PATIENT STANDS FOR A TOTAL OF ABOUT 30 MINUTES IN TOTAL AGAINST 15 MINUTES ACCORDING TO THE PRESCRIPTION. THE LOWERING FUNCTION IS FOUND NOT TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87769 EASYSTAND EVOLV STANDING FRAME INO ALTIMATE MEDICAL INC. EVOLV LARGE

    Patients

    Seq Age Sex Outcome Treatment
    1 Other