BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND EVOLV GLIDER

    MDR report key: 2271799 · Received September 19, 2011

    Report

    Report Number
    2183634-2011-00005
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 23, 2011
    Report Date
    September 16, 2011
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A RETURN AUTHORIZATION HAS BEEN ISSUED FOR THE BASE TO BE RETURNED, BUT AS OF THE DATE OF THIS REPORT THE BASE HAS NOT YET BEEN RETURNED.

    Description of Event or Problem · 1

    ON (B)(6), CUSTOMER SERVICE RECEIVED A PHONE CALL FROM AN INDEPENDENT REP THAT HE NEEDED TO ORDER A REPLACEMENT BASE AND REAR CASTERS FOR AN EASYSTAND AT A FACILITY IN HIS TERRITORY. HE STATED THAT THE CASTER HAD BROKEN OFF AND THEY WERE UNABLE TO REMOVE THE STEM FROM THE BASE. AN ATTEMPT WAS MADE TO GET MORE INFO REGARDING THIS ISSUE AND ON (B)(6) 2011, I SPOKE WITH AN INDIVIDUAL FROM THE FACILITY WHERE THIS ISSUE OCCURRED. HE STATED THAT A CLIENT WAS SITTING IN THE EASYSTAND AND WHEN THE ASSISTANT WENT TO MOVE THE CLIENT, HE NOTICED THAT ONE OF THE REAR CASTERS WAS TURNED IN THE WRONG POSITION TO THE SIDE. THE ASSISTANT STRAIGHTENED THE CASTER AND STARTED TO MOVE THE UNIT WHICH IS WHEN THE CASTER AGAIN TURNED TO THE SIDE AND BROKEN OFF THE UNIT. THE UNIT DID NOT FALL OR TIP OVER AND THE PT WAS NOT INJURED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other