BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASTYSTAND EVOLV

    MDR report key: 2676092 · Received July 26, 2012

    Report

    Report Number
    2183634-2012-00002
    Event Type
    Malfunction
    Date Received
    July 26, 2012
    Date of Event
    June 27, 2012
    Report Date
    June 28, 2012
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT EASYSTAND EVOLV WAS SHIPPED TO THE MEDICAL EQUIPMENT DEALER ON (B)(4) 2012. ONCE THE REPLACEMENT WAS RECEIVED AND DELIVERED THE EQUIPMENT DEALER WAS GOING TO SHIP BACK THE ORIGINAL EASYSTAND EVOLV FOR EVALUATION. AN E-MAIL AND TWO FOLLOW-UP CALLS HAVE BEEN MADE AS OF (B)4) 2012, AND ALTIMATE MEDICAL IS STILL WAITING TO HEAR BACK MORE INFORMATION REGARDING THIS ISSUE AND WHEN THIS EASYSTAND CAN BE RETURNED FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED AND THE EASYSTAND IS RETURNED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)6) 2012, ALTIMATE MEDICAL RECEIVED A CALL FROM AN INDEPENDENT REPRESENTATIVE THAT ONE OF HIS MEDICAL EQUIPMENT DEALERS HAD CONTACTED HIM REGARDING AN EASYSTAND EVOLV THAT WOULD NOT DESCEND TO THE SEATED POSITION. ALTIMATE MEDICAL WAS INFORMED THAT THIS USER HAD A SEIZURE WHILE IN THE STANDING FRAME; BUT HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION TO DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other