The initial meeting was to show the device and to take measurements of the user's body.The device was adjusted to meet the client's physical needs, and the device was returned for final fitting and operational with the end-user.Report indicates during the second meeting for evaluation of a standing wheelchair, during the evaluation as the user was being stood, they started to show signs of distress and discomfort.Report states the end-user was immediately removed from the seating and later taken to the hospital where they were diagnosed as having sustained a fracture to the right tibia.Reports indicate the user's family, dealer atp, and home health pt were present with the permobil representative.During the evaluation, no noticeable issues were seen, and all parties were acceptive of the users' positioning.After the end-user was removed from the m vs's seating, the permobil representative and user's father did a side-by-side comparison with the user's current home standing frame.It was noted that all measurements were nearly identical with minimal differences.The device was found to be fully operational with no mechanical or electrical deviations.It remains unclear to all parties present as to the root cause of the reported injury.The dhr was reviewed, and the device was found to have met specification prior to distribution.
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