BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND EVOLV

    MDR report key: 4490879 · Received February 4, 2015

    Report

    Report Number
    2183634-2015-00001
    Event Type
    Malfunction
    Date Received
    February 4, 2015
    Date of Event
    January 6, 2015
    Report Date
    January 6, 2015
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    ION
    PMA / PMN Number
    K062402
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON F/U ATTEMPTS TO OBTAIN ADD'L INFO, THE FACILITY HAS BEEN UNABLE TO PROVIDE ADD'L INFO AT THIS TIME. HOWEVER, THE FACILITY STATED THEY WILL KEEP IN CONTACT WITH AMI AND LET US KNOW WHEN THEY CAN PROVIDE ADD'L INFO. IN ADDITION, AMI HAS REQUESTED TO HAVE THE CASTER AND THE BASE RETURNED SO THIS ISSUE CAN BE INVESTIGATED. THE FACILITY IS UNABLE TO RETURN THE COMPONENTS AT THIS TIME BUT STATED IT WILL F/U WITH AMI IF AND/OR WHEN THEY CAN RETURN THE COMPONENTS TO AMI.

    Description of Event or Problem · 1

    ON (B)(6) 2015, ALTIMATE MEDICAL (AMI) CUSTOMER SVC RECEIVED A CALL FROM A FACILITY REGARDING A BROKEN THREAD ON A CASTER. THE FOLLOWING ADD'L INFO WAS OBTAINED ON (B)(6) 2015 FROM THE FACILITY: THE THREAD ON ONE OF THE BACK CASTERS BROKE AND THE BACK END OF THE FRAME WENT DOWN TO THE FLOOR., CAUSING THE STANDER TO BE UNEVEN. THE TEACHER SAW THIS AND HELPED THE CHILD IN THE UNIT LAY ON THE FLOOR. HELP ARRIVED AND THREE PEOPLE THEN STOOD THE STANDER BACK UP AND TWO MORE LIFTED THE CHILD OUT OF THE STANDER. THE NURSING STAFF AT THIS FACILITY CHECKED OVER THE CHILD AND HE APPEARED TO BE OK, HOWEVER, THE PARENT OF THE CHILD WANTED HIM TAKEN TO THE EMERGENCY ROOM BY AMBULANCE TO BE FURTHER CHECKED OUT. ON (B)(6) 2015 ATTEMPTS WERE MADE TO GATHER FURTHER INFO BUT THE FACILITY WAS UNABLE TO PROVIDE ANY FURTHER INFO AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    80947 EASYSTAND EVOLV 890.3110 ION ALTIMATE MEDICAL, INC. EVOLV MEDIUM NA

    Patients

    Seq Age Sex Outcome Treatment
    1