BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND EVOLV

    MDR report key: 15473284 · Received September 23, 2022

    Report

    Report Number
    2183634-2022-00002
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    June 21, 2022
    Report Date
    August 26, 2022
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETURN OF THE UNIT WAS ARRANGED FOR INSPECTION TO BE COMPLETED. THE STANDING FRAME WAS RETURNED TO AMI ON (B)(6) 2022 FOR INSPECTION AND WAS RETURNED TO AMI LOWERED IN THE SEATED POSITION. AFTER REVIEW OF THE STANDING FRAME, THERE WERE NO ISSUES FOUND. THE STANDING FRAME WAS FOUND TO ELEVATE TO THE FULL STANDING POSITION AND RETURN TO THE FULL SEATED POSITION WITHOUT ANY MALFUNCTION. THIS PROCESS WAS COMPLETED ON THE RETURNED UNIT MULTIPLE TIMES BY MULTIPLE OPERATORS ACROSS TWO DAYS AND INCLUDED EVALUATION WITH AN OCCUPANT IN THE UNIT AND THE UNOCCUPIED UNIT. IF THERE WAS NO PRESSURE BEING APPLIED TO THE SEAT BY THE OCCUPANT (OR ALSO IN THE CASE OF AN UNOCCUPIED UNIT), 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 BY PLACING THEIR HAND ON THE SEAT. IF THERE WAS SLIGHT PRESSURE BEING APPLIED BY THE OCCUPANT TO THE SEAT, THE UNIT WOULD RETURN TO THE FULL SEATED POSITION WHEN THE OPERATOR PUSHED BACK ON THE HANDLE. INCLUDED IN THE TROUBLE SHOOTING SECTION OF THE INSTRUCTIONS FOR USE IS THIS SECTION. MY EASYSTAND WILL NOT RELEASE PROPERLY FROM THE STANDING TO THE SEATED POSITION. -TRY PUSHING THE HANDLE BACK INTO DIFFERENT POSITIONS; DO NOT PUSH THE PUMP HANDLE BACK HARD INTO ONE 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 -ENSURE THE BACK ANGLE IS ADJUSTED PROPERLY, IF THE BACK ANGLE IS TOO FAR FORWARD OR BACK THE UNIT MAY NOT DESCEND PROPERLY. ADJUST THE BACK ANGLE TOWARD 90 DEGREES SO IT WILL RELEASE PROPERLY. THE DISTRIBUTOR IS REACHING OUT TO THE CUSTOMER TO INQUIRE ABOUT THE OPERATORS TRAINING, LEVEL OF EXPERIENCE WITH THE DEVICE AND IF THE INSTRUCTIONS FOR USE ARE MADE AVAILABLE TO THEIR OPERATORS.

    Description of Event or Problem · 0

    ON 08/26/2022 ALTIMATE MEDICAL RECEIVED NOTICE FROM THE DISTRIBUTOR IN SWEDEN THAT THERE HAD BEEN AN INCIDENT WITH AN EVOLV UNIT BEING STUCK IN THE STANDING POSITION, THAT THE USER HAD SENT A REPORT TO THE SWEDISH MEDICAL PRODUCTS AGENCY, AND THAT THEY WOULD WORK TO GET THE UNIT BACK FROM THE CUSTOMER. THERE WERE NO ADDITIONAL DETAILS PROVIDED AT THAT TIME. ON 8/30/2022 THE DISTRIBUTOR RECEIVED A COPY OF THE REPORT FILED WITH THE SWEDISH AUTHORITY AND SHARED IT WITH ALTIMATE MEDICAL ON 9/2/2022. UTILIZING GOOGLE TRANSLATE FROM SWEDISH TO ENGLISH, THE INCIDENT DETAILS WERE THAT THERE WAS A PATIENT STANDING IN AN EVOLV LARGE, WHICH IS MAXIMALLY RAISED. WHEN STANDING TRAINING IS FINISHED, IT IS NOT POSSIBLE TO LOWER THE STANDING SUPPORT. PATIENT BECOMES AGITATED AND SELF-HARMS BY BANGING HIS HEAD ON THE TABLE AND SLAPPING HIS HAND ON HIS HEAD. THE STAFF TRYING TO FIND AN EMERGENCY LOWERING, BUT THERE IS NONE. ASSISTIVE TECHNOLOGY CENTER IS CALLED TO GET INFORMATION ABOUT EMERGENCY LOWERING AND DURING THE CONVERSATION STAFF STILL MANAGE TO LOWER THE STANDING SUPPORT. ESTIMATED IT TOOK 10 MINUTES BEFORE THE STAND SUPPORT COULD BE LOWERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2752160 EASYSTAND EVOLV STANDING FRAME INO ALTIMATE MEDICAL, INC. EVOLV LARGE

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown