Re: medwatch form (b)(4).Dear (b)(6), on 1/8/2018, stanley healthcare (sh) received a medwatch report from your facility reporting device malfunctions.You reported an incident having occurred on approximately (b)(6) 2017.No injury was reported in the mdr filing.To date, none of the reported equipment has been returned to sh for further evaluation as requested.In the past, our company has sent compliance, engineering and product solutions staff to your facility to discuss recurring issues and observe the system in use.We have provided suggested best practices for your staff to adhere to ensuring our product is used properly.As my calls and emails have not been returned - i am closing out this filing citing no further action required by stanley healthcare.I would like to remind you of the following warning statements in the bed-check® cordless user guide: test the bed-check® monitor and sensormat® pad before each use and inspect the cords and pads for signs of damage.Replace any components with signs of wear or damage immediately.Check that the transmitter is switched on and that the status led on the monitor flashes green for at least 1 second when the reset button is pressed, or the status led flashes green for 0.5 seconds once per minute to indicate that it is monitoring the person.Operators of this equipment must be familiar with the functions and usage as described in this manual, and must be properly trained in the patient care policies and procedures of the facility.If you have any questions, please feel free to contact me at (b)(4).Sincerely, (b)(4), director of compliance.[(b)(4)].
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