Background information: reference medwatch report mw5089899 received at srm fresno on 10/1/2019.Serial number of chair was not provided; therefore, production records could not be reviewed.All sunrise medical power chairs are equipped with an electronic controller that conveys the user information to the chair to determine motion.This is performed through a serious of mechanical assemblies and software.Whenever a claim of malfunction is made due to the chair operating in a manner unexpected by the user, the technician's review the history to determine if there were any software faults.Lacking any software faults, they then perform an inspection of the equipment itself (hardware) to determine if there can be a short in a line (electrical cord) or connection.If no damage is found in the lines and the hardware is in good condition (does not show signs of damage), the inspection is determined to be a "no fault found." in the event of a no fault found, there is no malfunction of the product and any result consequence is determined to not be caused by nor contributed to by the chair.Therefore, no fault found complaints may not filed as mdrs if they did not cause or contribute to any resultant injury and likely will not contribute to any potential future injury.However, in the event that an injury did occur, a report may be filed if it is believed that the chair did contribute to the injury, even in the absence of a malfunction.Quickie pulse owner manual, p/n 119832, rev h, page 9, section m states: "1.Always turn off power before you transfer to or from your chair.If you fail to do so you may touch the joystick and cause your chair to move when you do not expect it.Discussion: at the time of the injury, it is uncertain as to the chair's condition.The medwatch form received by sunrise medical states that the staff were assisting the user, but provides no description of what type of assistance was being provided.If the staff were assisting the user transferring into or out of the chair, the owner manual states that the wheelchair must be turned off before performing transfer as the joystick may mistakenly be engaged.Because of the report filed (med watch mw5089899), this report is being filed as a supplement to that report and includes sunrise medical's investigation of the incident.And although there was a serious injury (skin tear requiring hospitalization and treatment), however, there is no indication of product malfunction.Conclusion: this incident, of its own accord, does not warrant a mdr filing.However, due to the medwatch filing (mw5089899), this incident is being filed as a follow-up with further investigation into the prior filing.There is no malfunction of the product that can be determined from the information provided.Serial number was not provided, therefore, production records cannot be reviewed.Nor was the subject wheelchair returned for evaluation.Sunrise medical considers this matter closed.Additional information: this complaint has been re-reviewed as a part of a four-year retrospective review and remediation effort based on enhancements made to the company's complaint handling and adverse event reporting processes.A legal consulting firm was consulted for the retrospective review.This mdr is being filed based on the outcome of that retrospective review.
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