BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYSTAND 5000

    MDR report key: 2597362 · Received May 29, 2012

    Report

    Report Number
    2183634-2012-00001
    Event Type
    Malfunction
    Date Received
    May 29, 2012
    Date of Event
    May 7, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    IKX
    PMA / PMN Number
    K885343
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS UNIT WAS MANUFACTURED IN 02/2004, THEREFORE THE UNIT WAS A LITTLE OVER 8 YEARS OLD, IN ADDITION THE UNIT WAS USED BY VARIOUS CLIENTS QUITE FREQUENTLY AT THIS FACILITY. THE MEDICAL EQUIPMENT DEALER PROVIDED ALTIMATE MEDICAL WITH THE FOLLOWING INFO WHEN HE REVIEWED THE EASYSTAND. HE STATED THAT HE THOUGHT THAT THE CASTER BOLT WAS ALLOWED TO LOOSEN AND BACK OUT WHICH CAUSED THE FRONT CASTER TO COME OFF. THE INSTRUCTIONS FOR USE INCLUDED IN THE PRODUCT OWNER'S MANUAL STATE THAT IT IS IMPORTANT AND NECESSARY THAT YOU INSPECT YOUR EASYSTAND 5000 PERIODICALLY TO ASSURE THAT IT IS IN SAFE OPERATING CONDITION. AT THE TIME WE SPOKE WITH THE THERAPIST AT THE FACILITY, SHE WAS UNABLE TO LOCATE THE PRODUCT OWNER'S MANUAL FOR THE EASYSTAND 5000. ALTIMATE MEDICAL'S INDEPENDENT REP AND THE MEDICAL EQUIPMENT DEALER PICKED UP THE EASYSTAND 5000 AND REPLACED IT WITH THE CURRENT MODEL EASYSTAND EVOLV. A CALL TAG HAS BEEN ISSUED FOR THE EASYSTAND 5000 BUT AS OF THE DATE OF THIS REPORT IT HAS YET TO BE RETURNED. IF ANY ADD'L INFO IS OBTAINED OTHER THAN WHAT IS ALREADY LISTED ABOVE, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, ALTIMATE MEDICAL RECEIVED A CALL FROM AN INDEPENDENT REP THAT ONE OF HIS MEDICAL EQUIPMENT DEALERS HAD CONTACTED HIM REGARDING ONE OF THE HOSPITALS IN HIS TERRITORY WHICH HAD AN EASYSTAND 5000. THE DEALER INFORMED HIM THAT THE EASYSTAND WAS APPROX 8 YEARS OLD AND THAT IT LOOKED TO HIM LIKE THE FRONT CASTER BOLT HAD BEEN ALLOWED TO WORK ITS WAY OUT OF THE BASE, CAUSING THE CASTER TO COME OFF, WHICH THEN CAUSED THE USER TO FALL FORWARD WHILE USING THE STANDING FRAME. THE THERAPIST AT THE HOSP WAS CONTACTED AND SHE STATED THAT THE CLIENT USING THE EASYSTAND WAS NOT INJURED, HE HAD STATED HIS CHEST WAS SORE BUT HE DECLINED TO GO TO THE ER AND GET CHECKED OVER. THE EASYSTAND WAS USED AT THIS FACILITY APPROX FOUR DAYS A WEEK BY 5 TO 6 DIFFERENT CLIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYSTAND 5000 890.5370 IKX ALTIMATE MEDICAL, INC. 5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other