BEUDAMED
    FDA Adverse Event Other Summary report: N

    EASYSTAND EVOLV

    MDR report key: 3313766 · Received August 20, 2013

    Report

    Report Number
    2183634-2013-00003
    Event Type
    Other
    Date Received
    August 20, 2013
    Date of Event
    August 6, 2013
    Report Date
    August 6, 2013
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    ION
    PMA / PMN Number
    K062402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERAPIST WENT TO VISIT THE HOME, REVIEW THE PRODUCT AND CREATE A CHECKLIST FOR THE NURSES THAT WORK WITH THIS PT. AT THAT TIME, THE THERAPIST VERIFIED THAT THE FAMILY HAD THE PRODUCT OWNER'S MANUAL WHICH INCLUDES THE INSTRUCTIONS FOR USE AND MAINTENANCE INSTRUCTIONS.

    Description of Event or Problem · 1

    RECEIVED A CALL FROM A PHYSICAL THERAPIST REQUESTING MORE INFO ON THE EASYSTAND EVOLV AS SHE WAS PUTTING TOGETHER A CHECKLIST TO TRAIN NURSES THAT WORK WITH A PT. AFTER FURTHER DISCUSSION, SHE INFORMED ME SHE HAD A PT THAT IS REQUIRED TO BE UNDER 24 HOURS SUPERVISION AND THERE HAD BEEN A SITUATION WHERE ONE OF THE NURSES CARING FOR THE PT HAD STEPPED AWAY BRIEFLY TO USE THE REST ROOM; DURING THIS TIME THE PT HAD A SEIZURE WHILE IN THE STANDING FRAME. THE PT WAS FOUND IN A FOLDED OVER POSITION IN THE STANDING FRAME WITH THE TABLE PUSHED FORWARD AND AS A RESULT THE PT SUFFERED A FRACTURED TIBIA. THE THERAPIST COULD NOT VERIFY EXACTLY HOW THIS OCCURRED, BUT SHE DID NOT BELIEVE THERE WAS ANYTHING WRONG WITH THE STANDING FRAME. SHE INFORMED ME THAT DUE TO THEIR INTERNAL PROTOCOL THAT THE NURSES COULD NOT USE THE STANDING FRAME UNTIL THEY WERE ALL PROPERLY TRAINED, WHICH IS WHY SHE WAS PUTTING TOGETHER A CHECKLIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404113 EASYSTAND EVOLV 890.3110 ION ALTIMATE MEDICAL, INC. EVOLV MEDIUM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other