BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSTAND EVOLV

    MDR report key: 4788130 · Received May 19, 2015

    Report

    Report Number
    2183634-2015-00004
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 20, 2015
    Report Date
    April 20, 2015
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EASYSTAND HAD BEEN DELIVERED TO THIS CLIENT ON (B)(6)2015. WHEN THE MEDICAL EQUIPMENT DEALER SHOWED THE CLIENT AND HIS FAMILY HOW TO USE THE STANDER, THE STANDER WORKED PROPERLY. BASED ON INFO OBTAINED REGARDING THIS CLIENT'S MEDICAL CONDITION, IT HAS BEEN DETERMINED THAT THE FOLLOWING MAY HAVE OCCURRED FOR THE STANDING FRAME NOT TO DESCENT PROPERLY. WITH THE MANUAL HYDRAULIC LIFE ON THE EASYSTAND EVOLV, WEIGHT NEEDS TO BE ON THE SEAT FOR THE UNIT TO PROPERLY DESCEND. DUE TO THIS CLIENT'S CONDITION, HE IS ABLE TO BEAR WEIGHT ON THIS LEGS WHICH MAY HAVE CAUSED THE USER'S WEIGHT NOT TO BE APPLIED TO THE SEAT WHEN TRYING TO DESCEND THE EASYSTAND. IN ADDITION, IF THE CLIENT WAS ALSO LEANING FORWARD INTO THE TABLE, WEIGHT MAY NOT HAVE BEEN APPLIED ON THE SEAT. DUE TO THE CONDITION OF THIS CLIENT, ALTIMATE MEDICAL, INC., REPLACED THE MANUAL HYDRAULIC LIFT WITH THE OPTIONAL POW'R UP LIFT AT NO CHARGE. THE POW'R UP LIFT OPTION ASCENDS AND DESCENDS AT THE TOUCH OF A BUTTON.

    Description of Event or Problem · 1

    ON (B)(6) 2015, ALTIMATE MEDICAL (AMI) CUSTOMER SVC RECEIVED AN EMAIL FROM AN INDEPENDENT REP THAT A MEDICAL EQUIPMENT DEALER CONTACTED HER REGARDING A CUSTOMER UNABLE TO GET THE HYDRAULIC PUMP TO RELEASE. ON (B)(6) 2015, (B)(6) FROM AMI SPOKE WITH THE CLIENT'S WIFE. SHE STATED HER HUSBAND HAD WANTED TO USE AN EASYSTAND TO HELP IMPROVE HIS STRENGTH. ON (B)(6) 2015, THE MEDICAL EQUIPMENT DEALER DELIVERED THE EASYSTAND AND SHOWED THEM HOW TO USE THE STANDER AND THE STANDER WORKED FINE. THE CLIENT DECIDED HE WANTED TO USE THE STANDER LATER THAT DAY, THEREFORE, HE ASKED HIS SON TO ASSIST HIM TO GET IN THE STANDER. AFTER APPROXIMATELY 10 MINUTES OF STANDING THE CLIENT DECIDED HE WANTED TO GET OUT OF THE UNIT. THE SON PUSHED THE PUMP HANDLE BACK, HOWEVER, THE STANDER DID NOT DESCEND. AS THE SON WAS WORKING ON TRYING TO GET THE STANDER TO DESCEND, ANOTHER 10 TO 15 MINUTES PASSED AND THE CLIENT PASSED OUT WHILE IN THE STANDING FRAME. THE CLIENT'S SON WAS ABLE TO GET HIM OUT OF THE STANDER AND TO HIS BED. THE CLIENT'S WIFE REPORTED THAT HE WAS NAUSEOUS AFTER HAVING PASSED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324090 EASYSTAND EVOLV 890.3110 INO ALTIMATE MEDICAL, INC. EVOLV LARGE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other