BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND EVOLV

    MDR report key: 4665291 · Received April 3, 2015

    Report

    Report Number
    2183634-2015-00003
    Event Type
    Malfunction
    Date Received
    April 3, 2015
    Date of Event
    December 31, 2014
    Report Date
    March 3, 2015
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EASYSTAND EVOLV WITH THE POW'R UP LIFT OPTION IS EQUIPPED WITH A MECHANICAL EMERGENCY RELEASE IN THE CASE OF THE BATTERY LOSING CHARGE OR ONE OF THE POW'R UP COMPONENTS NOT FUNCTIONING PROPERLY. THE MECHANICAL RELEASE IS ONLY TO BE USED IN EMERGENCY SITUATIONS AND HAS A FASTER DESCENT TO THE SEATED POSITION THAN THE NORMAL LOWERING FEATURE. THIS UNIT IS APPROXIMATELY EIGHT YEARS OLD THEREFORE ALTIMATE MEDICAL CONTACTED A MEDICAL EQUIPMENT DEALER TO COMPONENTS ON THE EASYSTAND. ALTIMATE MEDICAL SHIPPED THE MEDICAL EQUIPMENT DEALER THE PROPER REPLACEMENT PARTS FOR THIS EASYSTAND.

    Description of Event or Problem · 1

    ON (B)(6) 2015 AND END USER CONTACTED AMI CUSTOMER SERVICE STATING THAT ON (B)(6) 2014 HE SPOKE TO A GENTLEMEN IN THE CUSTOMER SERVICE AND TOLD HIM THAT HIS EASYSTAND WITH THE POWER UP LIFT OPTION RAISED HIM TO THE STANDING POSITION, BUT WOULD NOT LOWER. HE STATED HE WAS INFORMED TO USE THE MECHANICAL EMERGENCY RELEASE TO LOWER HIS STANDING FRAME TO THE SEATED POSITION. THE USER STATED HE HAD PAIN DUE TO USING THE MECHANICAL EMERGENCY RELEASE TO LOWER HIM FROM THE STANDING TO THE SEATED POSITION, AS THE UNIT DESCENDED QUICKLY. FOLLOW-UP CONTACT WAS MADE ON (B)(6) 2015, THE USER STATED THAT WHEN THEY ACTIVATED THE MECHANICAL EMERGENCY RELEASE TO LOWER HIM TO THE SEATED POSITION THAT THE UNIT DESCENDED QUICKLY FROM THE STANDING TO THE SEATED POSITION. AFTER THIS OCCURRED HE HAD PAIN IN HIS BACK/TAIL-BONE AREA. WHEN THE USER WAS ASKED IF HE OBTAINED MEDICAL TREATMENT FOR THIS HE STATED THAT HE DID NOT AS HE IS ALREADY ON PAIN MEDICATION FOR THE CONDITIONS THAT HE HAS; HOWEVER HE WAS TRYING TO SCHEDULE AN MRI, BUT HAD NOT YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224198 EASYSTAND EVOLV 890.3110 INO ALTIMATE MEDICAL, INC. EVOLV LARGE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other