BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPERSTAND

    MDR report key: 3204221 · Received June 24, 2013

    Report

    Report Number
    3007494904-2013-00002
    Event Type
    Other
    Date Received
    June 24, 2013
    Date of Event
    May 22, 2013
    Report Date
    June 21, 2013
    Manufacturer
    THE STANDING COMPANY
    Product Code
    IPL
    PMA / PMN Number
    K032101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLIENT SUFFERS FROM RECURRING CVA'S. HE HAS NEUROSARCOIDOSIS WITH BRAIN DYSFUNCTION, QUADRIPARESIS ON BOTH THE LEFT AND RIGHT SIDE, AND HE HAS IMPAIRED CORE STRENGTH AND BALANCE. HIS COGNITIVE SKILLS ARE VERY POOR. THE STANDING COMPANY BELIEVES THAT THE ROOT CAUSE OF THIS EVENT IS FROM THE CLIENT BEING LEFT ALONE FOR LONG PERIODS AT A TIME WITH NO SUPERVISION. THE CLIENT IS NOT CAPABLE OF PROPERLY FOLLOWING SAFETY PROTOCOL WITHOUT ADULT SUPERVISION. AFTER FAILING TO ATTACH HIS SAFETY BELT AND TIBIAS AS DIRECTED IN THE SAFE OPERATING PROCEDURES, HE SLIPPED OUT OF THE WHEELCHAIR ONTO THE FLOOR, RESULTING IN INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE STANDING COMPANY WAS NOTIFIED BY E-MAIL THAT THE CLIENT SLIPPED OUT OF HIS WHEELCHAIR AND LANDED ON HIS RIGHT KNEE. HE WAS HELPED BACK INTO HIS CHAIR BY EMS AND LEFT ALONE UNTIL HIS WIFE RETURNED FROM WORK SEVERAL HOURS LATER. APPROXIMATELY THREE DAYS LATER, THE CLIENT COMPLAINED OF PAIN IN HIS LEG AND WAS TAKEN TO THE HOSPITAL. TESTS SHOWED THAT HE HAD A BROKEN FEMUR JUST ABOVE THE KNEE. SURGERY WAS CONDUCTED TO REPAIR THE FEMUR. AN INVESTIGATION SHOWED THAT THE CLIENT HAS POOR COGNITIVE SKILLS AND IS LEFT ALONE FOR LONG PERIODS OF TIME DURING THE DAY TIME. THE CLIENT WAS ALONE WHEN HE ATTEMPTED TO STAND IN THE STANDING WHEELCHAIR. THE CLIENT ADMITTED THAT HE DID NOT FOLLOW THE SAFETY PROTOCOL. THE CLIENT'S WIFE SAID THAT HE FAILED TO BUCKLE HIS SAFETY BELT BEFORE STANDING. THE CLIENT'S WIFE ALSO SAID THAT HE FAILED TO ATTACH THE TIBIA SUPPORTS TOGETHER BEFORE STANDING. THE TIBIA SUPPORTS ARE WHAT KEEPS THE CLIENTS LEGS FROM COLLAPSING IN THE STANDING POSITION. THE STANDING COMPANY WAS NOT NOTIFIED OF THE EVENT UNTIL 19 DAYS AFTER IT HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284765 SUPERSTAND STAND UP WHEELCHAIR IPL THE STANDING COMPANY HPS-2

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization