BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSTAND EVOLV GLIDER

    MDR report key: 7643610 · Received June 27, 2018

    Report

    Report Number
    2183634-2018-00003
    Event Type
    Injury
    Date Received
    June 27, 2018
    Date of Event
    May 26, 2018
    Report Date
    June 1, 2018
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EASYSTAND EVOLV GLIDER WAS DESIGNED AS AN ACTIVE STANDER. THE GLIDER ALLOWS USERS TO MOVE THE HANDLES WITH THEIR ARMS WHICH CREATES RECIPROCAL MOVEMENT IN THE LEGS. THE GLIDER SEAT IS DESIGNED WITH HINGED BREAK-AWAY SECTIONS FOR EACH LEG WHICH ALLOWS THE USER TO GET FULL EXTENSION WHILE STANDING AND USING THE GLIDE HANDLES. THIS PATIENT USES A STATIONARY STANDER AT SCHOOL, THEREFORE ALSO WANTED A STANDER FOR HOME USE. BEING THERE WERE NO FUNDING SOURCES AVAILABLE FOR A NEW STANDER, THIS FAMILY PURCHASED A USED GLIDER FROM A 3RD PARTY. BASED ON THE SERIAL NUMBER PROVIDED TO ALTIMATE MEDICAL (AMI) THE GLIDER WAS ORIGINALLY MANUFACTURED AND SHIPPED IN 2009. WHEN SPEAKING TO THIS PATIENT'S FATHER, HE STATED THAT THEY USE THE GLIDER AS A STATIONARY STANDER 95% OF THE TIME AND OCCASIONALLY WILL MOVE THE GLIDE HANDLES, HOWEVER THAT IS NOT THE MAIN USE FOR THIS STANDER. DISCUSSED WITH THE FATHER THE REASON WHY THE SEAT ON THE GLIDER IS DESIGNED HOW IT IS (WHICH IS EXPLAINED ABOVE) AND EXPLAINED THAT WE COULD PROVIDE HIM WITH ONE OF THE FOLLOWING: A SEAT COVER, LOOKING AT A DIFFERENT SEAT, OR GETTING THEM A DIFFERENT STATIONARY STANDER (SIMILAR TO WHAT HIS SON USES AT SCHOOL). THE FAMILY CHOSE EXCHANGING THE EVOLV GLIDER THEY CURRENTLY HAVE FOR AN EVOLV LARGE STATIONARY STANDER. ALTIMATE MEDICAL'S INDEPENDENT REPRESENTATIVE IN IL WILL BE EXCHANGING THE UNITS AT THE END OF JUNE. PRODUCT HISTORY AND TRENDS WERE REVIEWED AND THIS APPEARS TO BE AN ISOLATED CASE. IT IS THE ONLY ISSUE OF ITS KIND LOGGED FOR THE EASYSTAND EVOLV GLIDER. UNDER TYPICAL USE CIRCUMSTANCES A PATIENT USING THE GLIDER WILL NOT HAVE THEIR FINGERS UNDERNEATH THEM WHEN GOING FROM THE STANDING TO THE SITTING POSITION. IN ADDITION, SINCE THIS DESIGN WAS RELEASED IN 2008, THERE ARE OVER (B)(4) GLIDERS IN THE FIELD AND THIS IS THE FIRST TIME WE HEARD OF THIS OCCURRING.

    Description of Event or Problem · 1

    RECEIVED A VOICEMAIL FROM A FATHER OF AN EASYSTAND USER ON FRIDAY AFTERNOON, (B)(6) 2018 REGARDING AN ISSUE WITH AN EVOLV GLIDER. HE STATED THAT THE TIP OF HIS SON'S FINGER HAD GOTTEN STUCK, SMASHED AND SUBSEQUENTLY FOUND OUT IT WAS BROKEN. RETURNED THE CALL ON MONDAY, 06/04/2018 AND RECEIVED FURTHER INFORMATION. THE FATHER HAD RELEASED HIS SON FROM THE STANDING POSITION TO THE SEATED POSITION AND STATED WHEN HE GOT TO THE SEATED POSITION HE THOUGHT THAT HIS SON WAS SITTING ON HIS HAND. HOWEVER, AFTER ABOUT A MINUTE HE REALIZED THAT HIS SON'S FINGER HAD GOTTEN IN BETWEEN THE GAP WHERE THE SEAT SEPARATES ON THE GLIDER DURING STANDING AND WAS SMASHED WHEN THE GLIDER WAS RELEASED FROM THE STANDING TO THE SEATED POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483836 EASYSTAND EVOLV GLIDER STANDING FRAME INO ALTIMATE MEDICAL, INC. GLIDER LARGE

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other