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(b)(4).On (b)(6) 2018 arjohuntleigh was notified about a complaint involving citadel plus bed.The reported incident took place at osf healthcare in the united states.Following the information reported the patient fell out of the bed.The facility staff was notified about patient's fall by internal facility alarm.As a consequence the patient did not sustain any injury.According to the information provided by the customer at the time the incident occurred the mattress of the bed was overinflated to the point that it exceeded the physical dimensions of the bed.This caused that the side rails of the bed could not be raised.Moreover bed's patient exit alarm was not set.The facility staff neither report problems with bed's operation to arjohuntleigh service nor request help from their internal biomed department.Furthermore they decided to place the patient on that bed.According to facility staff representative opinion, the mattress was overinflated due to the fact the air pressure inside the mattress was incorrectly set by the caregiver and the patient's exit alarm was not set as the facility staff was unaware on how to turn it on.After the incident the functionality of the bed was checked by the facility trainer and the staff.It confirmed that the bed was working as intended therefore no arjohuntleigh service visit was requested.The facility internal trainer informed arjohuntleigh service technician that the staff did not know how to operate the device correctly and that is the reason why he gave the supplementary training to the staff.The product instruction for use (#831.374 rev.B dated on (b)(6)-2015) which was supplied together with the involved device contains all crucial information and warnings which should be followed to ensure patient safety: "to minimize risk of falls or injury, the bed should always be in the lowest practical position when the patient is unattended", "(.) caregivers should assess risk and benefits of side rail use (including the entrapment an patient fall from bed) in conjunction with individual patient needs, and should discuss use or non-use with patient and/or family." "caregivers should always aid patient in exiting the bed.Make sure a capable patient knows how to get out of bed safely (.) ", "the patient movement detection system can be set to alarm when undesired movement of the patient occurs.The sensitivity of the patient movement detection, relative to the center of the deck, can be varied incrementally".In this particular case the patient was not supported while exiting the bed.Moreover the side rails were left in down position and no exit alarm was activated.Based on the above we can conclude that the user not following the recommendations in product instruction for use contributed to the incident.The complaint was decided to be reportable on a potential due to the allegation of patient's fall.The device was being used for patient care at the time of the incident.Upon the conducted investigation and bed inspection done by the arjohuntleigh representative, we were able to determine that user not following ifu contributed to the incident occurence.There was no technical deficiency found within the device.At the time the incident occurred the citadel plus bed met the manufacturer's specification.
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