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Hillrom was made aware of an event of a patient fall associated with a totalcare bed.No specific details of the event or patient injury were reported at the time of notification.Follow-up with the customer found that the patient sustained a fractured nasal bone, laceration of the right hand and the forehead.The patient subsequently expired six days following the event, the determined cause of death was not provided.The medical intervention included stitches for the lacerations (hand and forehead) as well as a ct of the patient's head.Additionally, the customer confirmed the bed was not connected to the facility's nurse call system at the time of the event.This patient was 80-years-old and was admitted for traumatic subarachnoid hemorrhage from a fall prior to admission, and had a medical history of asthma, htn, hld, tourette's syndrome, cva 11 years prior with lower limb extremity weakness (lle).The totalcare® bed system is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure injury; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The bed is equipped with a bed exit alert feature which provides an audible and visual alert notification to the caregiver team.However, it is not intended as a substitute for good nursing practices.The bed exit alarm system must be used in conjunction with a sound risk assessment and protocol.When the bed exit feature is armed and it detects an alert condition for the bed exit mode setting, the following occurs even if the patient returns to the bed: an audible alert comes on, the bed's amber alert silence control indicator flashes and a priority nurse call is sent to the nurse¿s station (for beds equipped and connected to a nurse call communication system).An inspection of the bed by a hillrom technician found the bed to be working as designed and noted that the bed's exit alarm was active at the time of the investigation and that its "audio alarm was in the off position." the technician turned on the audio to resolve the issue.The technician also noted that there was no nurse call communication cable (supplied by the customer) attached to the bed, thus the exit alert would not have been alerted through a nurse call system.In this event, the patient sustained a fall with injuries (nasal fracture, hand and forehead laceration) which required medical intervention of sutures to preclude permanent damage to body structure, thus concluding a serious injury occurred.Although the patient expired six days following the event, the determined cause of death is unknown, therefore it cannot be determined if it was related to the reported fall injuries or other medical conditions.The cause of this event is likely due to use error (turning off the exit alarm audio), as it is noted the inspection ruled out a device malfunction.If additional information becomes available, the complaint will be updated accordingly.
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