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(b)(4).When reviewing similar reportable events for rotoprone, we have not found another event with similar fault description compared to the one investigated here: inability or difficulty to putting the pt back into the prone position during an emergency situation.There is no trend observed for reportable complaints with this type of event for the rotoprone devices.Based on the info collected to date, provided problem description and inspection of the device, we have been able to establish that the following sequence of events likely occurred and lead to the reported outcome: in an emergency situation the nurse have activated automatic cpr button to rotate the pt supine so the pt could be treated for the tachycardia.However the device stopped in the half-way between prone and supine position at the same time the alarm indicating that one of the buckle is opened was triggered.In accordance to the device labeling, user manual (eg #208662-ah) which is delivered to the customer with each rented device, section 'powered cpr': one of the first steps while using the automatic cpr is to close any open hatches and ensure that hatch latches are secured.The bed movement (into the supine position) will stop if an unsafe operating condition occurs (eg opened hatch).Up to this point there is no indication of the device malfunctioning, it was working up to the spec.; as the automatic rotation stopped, the nursing staff manually rotated the bed back to the supine position.The device labeling describes the procedure for the emergency release for cpr-supine position with the following steps: close any open hatches, ensure hatch latches are secure; pull emergency release handle toward foot of unit to disengage belt drive (the emergency release handle in secured by beaded tie, in order to use this function the tie need to be opposite direction from which the unit was proned.There is also an info that the engagement of the emergency release feature disarm all safety alarms.Based on the device eval it has been conducted that the emergency release function was not activated by the facility staff, as the beaded tie, securing the lever, was intact.It has been also noticed that the tab securing the door allowing the access to the manual rotation lever was broken.The manual rotation lever is used when the manual rotation to proned position is required (e.G.In situation of loss of power).Based on this evaluation it seems most likely that during an emergency situation, facility staff used wrong lever - manual rotation lever instead of emergency release handle.This would also explain the comments that during this event putting the bed manually into the supine position was more difficult than before.The device involved in the event was found to be to specification, no failure has been found.In order to reduce the occurrence of incorrect usage of the device in an emergency situation, the device user manual include the following safety information: caregivers and other hospital personnel are required to become familiar with the cpr function and the emergency release procedures for automatically or manually rotating the patient surface, as well as the other procedures required to access the patient in case of an emergency.As this event appears to have been caused by a series of user errors.A re-training of the device functionality has been offered to the facility.In summary, the device was being used at the time of the event, it failed to meet its specifications as it did not suffer a malfunction but stopped performing as intended due to a use error, and in doing so it contributed to the outcome of the event- delay in providing the cpr to the patient.Unfortunately, the patient died the following day.Given the circumstances this incident appears to be caused by a series of user errors.We shall continue to monitor for any further events of this nature and do not propose any further action at this time.
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