BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVACARE ROZE STAND-UP LIFT

    MDR report key: 7324327 · Received March 8, 2018

    Report

    Report Number
    9616091-2018-00007
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    January 31, 2018
    Report Date
    February 8, 2018
    Manufacturer
    INVAMEX
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROZE LIFT AND R130 SLING WERE RETURNED TO INVACARE. AN EVALUATION CONFIRMED THAT NEITHER THE LIFT NOR THE SLING HAD ANY DEFECT OR MALFUNCTION. THROUGH EXAMINATION OF THE DEVICES THROUGH VISUAL INSPECTION AND FUNCTIONAL TESTING, IT WAS DETERMINED THAT THE DEVICES FUNCTIONED AS INTENDED WITHOUT ANY COMPLICATIONS. THE MOST LIKELY CAUSE OF THE REPORTED EVENT WAS THAT EITHER THE ROZE LIFT WITH STANDING SLING WAS NOT APPROPRIATE FOR THE PATIENT AND/OR THE PATIENT WAS IMPROPERLY POSITIONED DURING TRANSFER. THE ROZE STAND UP PATIENT LIFT OWNER'S MANUAL STATES, "INDIVIDUALS THAT USE THE STAND ASSIST SLING MUST BE ABLE TO SUPPORT THE MAJORITY OF THEIR OWN WEIGHT. BEFORE LIFTING THE PATIENT, MAKE SURE THE BOTTOM EDGE OF THE STANDING PATIENT SLING IS POSITIONED ON THE LOWER BACK OF THE PATIENT AND THE PATIENT¿S ARMS ARE OUTSIDE THE STANDING PATIENT SLING. THE BELT MUST BE SNUG, BUT COMFORTABLE ON THE PATIENT, OTHERWISE THE PATIENT CAN SLIDE OUT OF THE SLING DURING TRANSFER." THE MANUAL ADVISES THAT WHEN LIFTING THE PATIENT, THE OPERATOR SHOULD INSTRUCT THE PATIENT TO HOLD ONTO THE HAND GRIPS ON BOTH SIDES OF THE STAND UP LIFT, INSTRUCT THE PATIENT TO LEAN BACK INTO THE STANDING SLING, ENSURE THAT THE PATIENT¿S KNEES ARE SECURE AGAINST THE KNEE PAD, AND ENSURE THAT THE PATIENT¿S FEET ARE PROPERLY POSITIONED ON THE FOOT PLATE. (B)(4).

    Description of Event or Problem · 1

    THE FACILITY ADMINISTRATOR REPORTED TO THE DEALER THAT A CERTIFIED NURSING ASSISTANT LIFTED THE PATIENT IN THE ROZE STANDUP LIFT WITH AN R130 STANDING SLING AND THEN WENT AROUND THE LIFT TO RETRIEVE THE HAND PENDANT. THE PATIENT ADVISED THAT SHE WAS SLIDING OFF THE SLING, AND SHE LET GO OF THE HAND GRIPS. THE PATIENT DID NOT FALL OUT OF THE SLING, BUT HER KNEES SLID INTO THE KNEE PAD. AFTERWARDS, THE PATIENT HAD PAIN IN HER RIGHT KNEE, AND IT WAS SWOLLEN. ON (B)(6) 2018, THE PATIENT SAW AN ORTHOPEDIC DOCTOR AND WAS SENT TO HOSPITAL WHERE THEY FOUND THAT SHE HAD BROKEN FEMUR. ON (B)(6) 2018 SHE UNDERWENT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167308 INVACARE ROZE STAND-UP LIFT LIFT, PATIENT, NON-AC-POWERED FSA INVAMEX ROZE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R