BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND EVOLV

    MDR report key: 2057623 · Received March 7, 2011

    Report

    Report Number
    2183634-2011-00003
    Event Type
    Malfunction
    Date Received
    March 7, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EASYSTAND EVOLV IS IN THE PROCESS OF BEING RETURNED TO ALTIMATE MEDICAL SO AN EVAL CAN BE PERFORMED.

    Description of Event or Problem · 1

    RECEIVED A PHONE CALL FROM A SALES REP IN (B)(4) THAT ONE OF THE REAR CASTERS BROKE OFF AN EASYSTAND EVOLV ADULT WHEN THE PT'S ASSISTANT WENT TO MOVE THE PT TOWARDS THE T.V. THE PT'S ASSISTANT WENT TO CATCH THE PT AND WITH THE WEIGHT OF THE STANDER AND THE WEIGHT OF THE CLIENT, THE ASSISTANT AND THE USER ENDED UP APPROX AN ARM'S LENGTH FROM THE FLOOR. ALTIMATE MEDICAL WAS INFORMED THAT THE MOTHER OF THE PT PURCHASED THE PT A NECK BRACE FOR HER TO USE AFTER THIS INCIDENT. IN ADDITION WE WERE INFORMED THAT THIS PT'S DOCTOR WAS ON HOLIDAY WHEN THIS OCCURRED BUT THAT THIS PT WAS PLANNING TO SEE HER DOCTOR THE FOLLOWING WEEK. ALTIMATE MEDICAL WAS ALSO INFORMED THAT THIS PT'S PHYSIOTHERAPIST HAD RECOMMENDED THIS PT GET X-RAYS, BUT AS OF THE DATE THIS REPORT WAS SUBMITTED WE HAVE BEEN UNABLE TO OBTAIN ANY FURTHER INFO REGARDING THE PT OR THE ASSISTANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Other