BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND EVOLV ADULT

    MDR report key: 7353221 · Received March 20, 2018

    Report

    Report Number
    2183634-2018-00002
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    December 10, 2017
    Report Date
    February 22, 2018
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS STANDING FRAME WAS ORIGINALLY SHIPPED IN JULY 2009, THEREFORE IS APPROXIMATELY 8 1/2 YEARS OLD. THE DISTRIBUTOR THOUGHT THAT THIS PATIENT HAD BEEN THE SECOND USER OF THE PRODUCT AS HE RECEIVED THIS PRODUCT IN 2014. THIS STANDING FRAME WAS USED 2-3 TIMES PER DAY. ADDITIONAL INFORMATION PROVIDED BY THE DISTRIBUTOR WAS THAT MINOR MAINTENANCE CHECK-UPS WERE DONE EVERY 6 MONTHS OR SO. IN AUGUST 2016 ONE OF THE CASTERS WAS REPAIRED, DUE TO A SCREW COMING LOOSE, HOWEVER IT COULD NOT BE DETERMINED WHICH CASTER WAS REPAIRED. THE UNIT WAS SHIPPED BACK AND AFTER INSPECTION OF THE RETURNED UNIT IT WAS CONFIRMED THAT THE CASTER BROKE OFF AT THE STEM AS PART OF THE STEM WAS STILL IN THE BASE. THE ACTUAL CASTER THAT HAD BROKEN WAS NOT SHIPPED BACK WITH THE UNIT. THE OTHER CASTER THAT WAS STILL ATTACHED TO THE UNIT WAS NOT THREADED IN ALL THE WAY TIGHT TO THE BASE. THE DISTRIBUTOR WAS CONTACTED REGARDING THE BROKEN CASTER AND THEY WERE UNABLE TO LOCATE THE CASTER. THIS UNIT WAS PAST ITS ESTIMATED LIFE. IN ADDITION, WHEN THE CASTER IS THREADED TIGHT UP TO THE BASE THE PRESSURE ON THE CASTER IS DISTRIBUTED THROUGHOUT THE BASE THAT CONTAINS THE STEM. WHEN THE CASTER IS NOT THREADED ALL THE WAY INTO THE BASE THE PRESSURE MOVES FROM THE BASE OF THE STEM TO THE CASTER STEM. THE CASTER STEM ALONE MAY NOT BE ABLE TO WITHSTAND THE ADDED PRESSURE AND IN THIS CASE, IT HAD BROKEN. THE DISTRIBUTOR REPLACED THIS UNIT WITH A NEW UNIT.

    Description of Event or Problem · 1

    RECEIVED AN EMAIL FROM (B)(6) THAT A USER INCIDENT REPORT WAS SUBMITTED REGARDING AN EASYSTAND EVOLV. THE REPORT IS IN THE (B)(6) LANGUAGE. ROUGH TRANSLATION OF THE INCIDENT FROM THE DISTRIBUTOR IS: THE PATIENT WAS BEING RAISED IN THE EASYSTAND. IN THE MIDDLE OF THE UPWARD MOTION THE BOLT ON THE CASTER BROKE AND THE EASYSTAND BEGAN TO FALL. PERSONNEL WERE ABLE TO CATCH THE PATIENT AND THERE WAS NO PHYSICAL HARM. THIS EMAIL WAS SENT TO AN AMI CUSTOMER SERVICE REP ON 2/20/18, HOWEVER IT WENT INTO HER SPAM EMAIL AND WAS NOT LOCATED UNTIL 2/22/18, WHICH IS THE DAY AMI WAS MADE AWARE OF THIS ISSUE. THE DISTRIBUTOR WAS CONTACTED ON 2/22/18 TO OBTAIN MORE INFORMATION ABOUT THE PRODUCT AND THAT WE WOULD LIKE THE PRODUCT BACK TO INVESTIGATE. AMI'S EU REGULATORY REP WAS ALSO NOTIFIED AND WILL ASSIST IN SUBMITTING THE MANUFACTURER REPORT TO THE COMPETENT AUTHORITY IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194688 EASYSTAND EVOLV ADULT STANDING FRAME INO ALTIMATE MEDICAL, INC. EVOLV ADULT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other