BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EASYSTAND EVOLV LARGE

    MDR report key: 12929316 · Received December 3, 2021

    Report

    Report Number
    2183634-2021-00003
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    November 1, 2021
    Report Date
    November 3, 2021
    Manufacturer
    ALTIMATE MEDICAL, INC.
    Product Code
    INO
    PMA / PMN Number
    K062402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALTIMATE MEDICAL INC.'S QUALITY TEAM FOLLOWED UP WITH THE SITE'S BIOMED TEAM AND PROGRAM DIRECTOR FOR THE REHABILITATION PROGRAM TO GATHER ADDITIONAL INFORMATION REGARDING THE INCIDENT. THE ADDITIONAL INFORMATION OUTLINED THAT "HE WAS STANDING, AND THE BACK NEEDED TO BE ADJUSTED. WHEN THE WHEEL FELL OFF THE BACK, THE ENTIRE SYSTEM JACKKNIFED, AND HE WAS PUSHED FORWARD RAPIDLY INTO A FLEXED POSITION. THIS CAUSED HIM BACK PAIN AND STRAIN. HE WAS SEEN BY THE PHYSICIAN - SHE ORDERED X-RAYS TO CLEAR HIM. HE EXPERIENCED PAIN BUT ONCE RESOLVED, THERE WERE NO FURTHER COMPLAINTS OR EVIDENCE OF PERMANENT INJURY." AN EVOLV LARGE FROM ANOTHER LOT/BATCH WITH A SIMILAR SET OF OPTIONS WAS USED DURING THE INVESTIGATION TO TRY TO DUPLICATE THE ISSUE. WITH THE UNOCCUPIED UNIT IN A PARTIAL STANDING POSITION, WHEN THE SET SCREW WAS REMOVED FROM THE BACK ANGLE ADJUSTMENT WHEEL AND THEN THE WHEEL WAS BACKED OFF THE FOLLOWING ARM, THE JAM NUT STAYED IN PLACE ON THE FOLLOWING ARM AND THE BACK DID NOT MOVE FORWARD. WITH THE UNOCCUPIED UNIT IN A PARTIAL STANDING POSITION, WHEN THE WHEEL WAS BACKED OFF AND THE JAM NUT WAS ALSO BACKED OFF, THE BACK MOVED FORWARD RAPIDLY. WITH THE UNOCCUPIED UNIT IN A SEATED POSITION, WHEN THE WHEEL WAS BACKED OFF AND THE JAM NUT WAS ALSO BACKED OFF, THE FOLLOWING ARM WOULD NOT SEPARATE FAR ENOUGH FOR THE BACK SUPPORT TO MOVE FORWARD RAPIDLY. ADDITIONALLY, THE TRAY WOULD REST ON THE KNEE SUPPORT ASSEMBLY PREVENTING THE RAPID MOVEMENT. THE SAFETY PRECAUTIONS SECTION OF THE OWNER'S MANUAL INCLUDES THE STATEMENT: "NEVER MAKE ADJUSTMENTS TO THE EASYSTAND WHILE A USER IS IN THE STANDING POSITION". THE ADJUSTING YOUR EASYSTAND EVOLV SECTION OF THE OWNER'S MANUAL INCLUDES THE STATEMENT "CAUTION: THESE ADJUSTMENTS ARE ONLY TO BE MADE WHILE THE UNIT IS IN THE SEATED POSITION" AND "FIG L - LOOSEN THE KNOB ON THE SEAT TUBE LOCATED UNDER THE SEAT. DO NOT UNSCREW SEAT DEPTH KNOB ALL THE WAY WHEN ADJUSTING THE SEAT." WITHIN THE SEAT DEPTH/BACK ANGLE SEGMENT OF THAT SECTION. THE PERFECT FIT GUIDE PORTION OF THE OWNER'S MANUAL INCLUDES THE STATEMENT "CAUTION: THESE ADJUSTMENTS ARE ONLY TO BE MADE WHILE THE UNIT IS IN THE SEATED POSITION." WHICH IS FOLLOWED BY THE STEP TO ADJUST THE BACK ANGLE. THE FIT GUIDE IS ALSO ATTACHED TO THE UNITS AS A HANG TAG WHEN THEY ARE DISTRIBUTED. IN THE STANDING SECTION OF THE OWNER'S MANUAL IS THE STATEMENT "CAUTION: NEVER MAKE ADJUSTMENTS TO THE EASYSTAND WHILE A USER IS IN THE STANDING POSITION." THE SAFETY PRECAUTIONS SECTION OF THE OWNER'S MANUAL INCLUDES THE STATEMENT: "CHECK YOUR EASYSTAND PERIODICALLY TO MAKE SURE THAT ALL NUTS, BOLTS AND ADJUSTABLE PARTS ARE TIGHTENED SECURELY." THE MAINTENANCE SECTION OF THE OWNER'S MANUAL INCLUDES THE STATEMENT "CHECK YOUR EASYSTAND PERIODICALLY TO MAKE SURE THAT ALL NUTS, BOLTS AND ADJUSTABLE PARTS ARE TIGHTENED SECURELY". THE DEVICE HISTORY WAS REVIEWED AND IN AUGUST 2017 A BACK ADJUSTMENT WHEEL WAS ORDERED. THIS IS THE FIRST AND ONLY RECORDED ISSUE/COMPLAINT ALLEGING THE BACK ANGLE ADJUSTMENT WHEEL AND JAM NUT CAME OFF OF THE FOLLOWING ARM. BASED ON PRODUCT HISTORY, THERE ARE NO TRENDS TO INDICATE A PRODUCT ISSUE. THE EVOLV LINE WAS RELEASED TO THE MARKET IN 2005, OVER (B)(4) HAVE BEEN DISTRIBUTED. ALTIMATE MEDICAL'S CUSTOMER SERVICE TEAM ADDRESSED THE ISSUE AND PROVIDED THE CUSTOMER WITH A COMPLETE NEW BACK ASSEMBLY FOR THEIR EVOLV LARGE STANDER. ALTIMATE MEDICAL'S INDEPENDENT REP WILL BE MAKING THE BACK ASSEMBLY REPLACEMENT AND INSPECTING THE CUSTOMER'S OTHER EVOLV UNITS. ALTIMATE MEDICAL'S QUALITY TEAM HAS ALSO CONTACTED THE CUSTOMER AND INFORMED THEM OF THE SAFETY PRECAUTIONS WHEN MAKING A BACK ANGLE ADJUSTMENT AND IS PROVIDING THEM WITH ADDITIONAL FIT GUIDE HANG TAGS AND OWNER'S MANUALS AND THE LINK TO THE ONLINE OWNER'S MANUAL.

    Description of Event or Problem · 0

    ALTIMATE MEDICAL INC.'S QUALITY TEAM RECEIVED A PHONE CALL FROM A BIOMED TECHNICIAN ON WEDNESDAY NOVEMBER 3, 2021, REGARDING AN INCIDENT THAT OCCURRED WITH AN EVOLV LARGE AT THEIR FACILITY ON (B)(6) 2021. THE TECHNICIAN STATED THAT THE BACK ANGLE ADJUSTMENT WHEEL CAME OFF OF THE FOLLOWING ARM. WHEN ASKED IF THE JAM NUT ON THE FOLLOWING ARM ALSO CAME OFF HE SAID YES. WHEN THIS OCCURRED, THE BACK ABRUPTLY COLLAPSED FORWARD PUSHING THE PATIENT FORWARD AND THE PATIENT SUSTAINED AN INJURY. NO DETAILS REGARDING THE INJURY WERE PROVIDED AT THAT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823302 EASYSTAND EVOLV LARGE CHAIR, POSITIONING, ELECTRIC INO ALTIMATE MEDICAL, INC. EVOLV LARGE

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Other