BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSTAND EVOLV

    MDR report key: 4124960 · Received September 24, 2014

    Report

    Report Number
    2183634-2014-00003
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP CONTACT WAS MADE WITH THE MEDICAL EQUIPMENT DEALER, WHO INFORMED ME THAT WHILE HE WAS AT THE HOME AND ONCE WEIGHT WAS PUT ON THE SEAT, THE STANDING FRAME DESCENDED TO THE SEATED POSITION. HE STATED THAT UPON HIS INSPECTION OF THE STANDING FRAME, IT WAS FUNCTIONING PROPERLY. HE TOLD ME TO CONTACT THE CAREGIVER FOR MORE INFORMATION. WHEN CONTACTING THE CAREGIVER SHE CONFIRMED WHAT HAD OCCURRED AND ALSO STATED THAT SHE WAS NOT AWARE THAT WEIGHT NEEDED TO BE ON THE SEAT FOR THE UNIT TO DESCEND. ALTIMATE CONFIRMED THAT THE CAREGIVER DID HAVE AN OWNER'S MANUAL, WHICH INCLUDES THE INSTRUCTIONS FOR USE. DURING THE CONVERSATION WITH THE CAREGIVER SHE STATED SHE DISCUSSED WITH THE MEDICAL EQUIPMENT DEALER THAT SHE WANTED A STANDING FRAME WITH A POWERED LIFT AND NOT ONE WITH THE HYDRAULIC LIFT. FOLLOW-UP WAS MADE WITH THE MEDICAL EQUIPMENT DEALER WHO STATED THAT AN ORDER FOR A POWER UP LIFT FOR THE STANDING FRAME WAS IN PROCESS.

    Description of Event or Problem · 1

    CUSTOMER SERVICE RECEIVED A CALL FROM A DEALER WHILE HE WAS AT A CLIENT'S HOME REGARDING ASSISTANCE ON GETTING AN EASY-STAND EVOLV TO DESCEND TO THE SEATED POSITION. CUSTOMER SERVICE REVIEWED WITH THE DEALER AND THE CAREGIVER THAT WEIGHT NEEDS TO BE APPLIED TO THE SEAT FOR THE UNIT TO PROPERLY DESCEND TO THE SEATED POSITION. DURING THIS CALL CUSTOMER SERVICE WAS ALSO INFORMED THAT THE UNIT WOULD NOT DESCEND PROPERLY OVER THE WEEKEND AND AS A RESULT OF THIS, THE TABLE WAS REMOVED AND THE CLIENT WAS TAKEN OUT OF THE STANDING FRAME FROM THE FRONT BY USING A LIFT. WHEN BEING TAKEN OUT OF THE EASY-STAND FROM THE FRONT USING A LIFT THE CLIENT'S FEEDING TUBE CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595669 EASYSTAND EVOLV 890.3110 INO ALTIMATE MEDICAL, INC. EVOLV LARGE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other