BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND EVOLV GLIDER

    MDR report key: 5264129 · Received December 3, 2015

    Report

    Report Number
    2183634-2015-00005
    Event Type
    Malfunction
    Date Received
    December 3, 2015
    Date of Event
    November 3, 2015
    Report Date
    November 4, 2015
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CLIENT'S MEDICAL EQUIPMENT DEALER WAS CONTACTED REGARDING THIS ISSUE AND STATED HE WAS AWARE OF THE ISSUE AND THAT THE KNOB ON THE BACK OF THE SEAT THAT ADJUSTS THE BACK ANGLE WAS BEING MOVED. A PHOTO OF THE STANDING FRAME WAS REQUESTED AND AFTER REVIEWING THE PHOTO IT WAS NOTED THAT THE BACK ANGLE WAS OUT OF ADJUSTMENT WHICH CAUSED THE STANDING FRAME TO NOT PROPERLY DESCEND TO THE SEATED POSITION. THE PRODUCT OWNER'S MANUAL AND THE PERFECT FIT GUIDE (WHICH ARE PROVIDED WITH EACH UNIT) INCLUDES INFORMATION REGARDING PROPER BACK ANGLE ADJUSTMENT. IN ADDITION TO THE OWNER'S MANUAL, ALTIMATE MEDICAL INFORMED THE CLIENT'S MEDICAL EQUIPMENT DEALER THAT THERE ARE COMPONENTS FOR A FOLLOWING ARM STOP THAT CAN BE PROVIDED FOR THIS UNIT. THIS STOP PREVENTS THE BACK ANGLE FROM BEING ADJUSTED TOO FAR OUT OF ADJUSTMENT. AFTER DISCUSSING THIS WITH THE CLIENT'S MEDICAL EQUIPMENT DEALER, ALTIMATE MEDICAL SHIPPED THESE COMPONENTS TO THE MEDICAL EQUIPMENT DEALER WHO WILL ASSEMBLE THE COMPONENTS ON TO THIS CLIENT'S STANDING FRAME.

    Description of Event or Problem · 1

    ON (B)(6) 2015, RECEIVED AN EMAIL FROM AN EASYSTAND USER THAT HIS STANDING FRAME DID NOT DESCEND TO THE SEATED POSITION AND THAT HE AND HIS CAREGIVER CALLED 911 FOR ASSISTANCE TO GET HIM OUT OF THE STANDING FRAME. A FOLLOW-UP PHONE CALL WAS MADE TO THE USER ON (B)(6) 2015 AND HE STATED HE HAD NO INJURIES AND WAS IN THE STANDING FRAME FOR APPROXIMATELY ONE HOUR BEFORE HELP ARRIVED AND THEY WERE ABLE TO LIFT HIM OUT OF THE UNIT. HE ALSO STATED THAT HE USES HIS EASYSTAND EVERY DAY FOR ONE AND A HALF HOURS EACH DAY AND THAT HE IS VERY COMFORTABLE WHILE USING THE EASYSTAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794020 EASYSTAND EVOLV GLIDER STANDING FRAME INO ALTIMATE MEDICAL, INC. EVOLV GLIDER LARGE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other