|
(b)(4).When reviewing similar reportable events for enterprise 9000 beds, we have not found any similar fault description compared to the situation investigated here: pt fell down during exiting the bed and the varizone system triggering the alarm with a delay.There is no trend observed for reportable complaints with this complex failure description for enterprise bed.The design of the enterprise 9000 bed is that there are two split safety sides on each side of the bed that provide a barrier from the top of the head section to approximately below the knee, leaving a gap at the foot end of the bed which allows the pt to exit the bed when needed.In accordance to the product ifu (e.G.Ifu #746-579_03), which is attached to each enterprise bed, model 9800, the safety side rails are not intended to restrain pts who make a deliberate attempt to exit the bed.Additionally to reduce the risk of injury due to falls, the bed should be left at minimum height when the pt is unattended.Also the age, size and condition of the pt should be assessed by a clinically qualified person in order to ensure that they can use the bed safely.In this event, the pt wanted to leave the bed using the bag at the foot end of the device, as the safety side panels were left in raise position.It seems the most likely that the pt was too weak to support themselves and therefore fell down.Up to this point there is no indication that the device caused or contributed to the pt to fall from the bed.One of the features of the device involved in the vent is a varizone movement detection system which can be set to alarm for undesired an movement of the pt.The sensitivity of the movement detection, relative to the center of the mattress platform, can be varied incrementally.If the threshold of movement detection is triggered, an alarm will wound and the threshold indicator on the control panel will flash.Before the event, the threshold of the pt's movement (which triggers the alarm) had been set on the highest value - '1' which represents the 'out of bed' position.In this incident the alarm has sound when the pt left the bed, however this here is a question about the delay with which the varizone system's buzzer was sound.The respond time for the varizone system, set on the highest threshold 'out of bed' is approximately 1 s.Unfortunately, despite out best efforts it is unk what was the amount of the delay claimed by the facility.The arjohuntleigh representative inspecting the bed has tested the varizone system - the time for the triggering the alarm after standing up form the bed was a bit longer than 1s - it took 1.09s.This delay is seems to be negligible, difficult to notice by the user or a caregiver and therefore we (arjohuntleigh) do see it within the category of the malfunction.It is also very important that at the time of event the movement threshold was set on the highest level, alarm after the pt stand up from the bed.If the caregiver would like to be notified that the person is trying to stand up from the bed, the movement threshold activating the alarm should be set on the lower level.In summary, the device was being used, when the event occurred, for the pt treatment, the device contributed to the event since the pt fell down from the device; however, we could not establish any malfunction and therefore could not find that the device failed to meet its specification.Given the circumstances and the number of similar events, this incident appears to be an isolated issue.We shall continue to monitor for any further events of this nature and dot not propose any further action at this time.
|
