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The customer reported that the bed exit alarm of the centrella bed did not work and there was an unwitnessed fall.The customer stated that a caregiver was alerted by an alarm from the patient¿s room described as "different than normal" and initially thought to be the bed's heart and respiratory rate monitor (hrrm), and upon entering the room, the caregiver found the patient on the floor unconscious.The patient was noted to have a forehead indentation, right rib bruises and a skin tear.Medical intervention provided included a "higher level of care" and attempted radiology imaging, no additional intervention was reported.It was reported the patient subsequently expired later in the day (same day of the event) with the cause of death determined to be a gi bleed.During a follow up call with the customer, the customer stated that the event is contributed to the bed not being connected to the facility's nurse call system.Of note, this facility utilizes a third-party nurse call system.The customer confirmed that the bed's exit alarm was heard by a caregiver and the caregiver responded appropriately.It was also reported after the event during the bed¿s cleaning process the evs personnel noted that upon connecting the bed to ac power the bed¿s exit alarm continued to alarm requiring them to disarm the alarm, showing the alarm was functional.This patient was admitted for postural dizziness with near syncope and had a medical history of colon cancer with colon resection, copd with chronic respiratory failure, hypomagnesemia, hypocalcemia, weight loss, falls, respiratory failure, and gi bleed.The centrella® smart+ bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.It is intended for a broad patient population as determined appropriate by the caregiver or institution.It is intended for patient populations weighing at least 70 lbs.(32 kg) and is capable of supporting patients up to 500 lbs.(227 kg).The bed is equipped with a bed exit alert system and a heart and respiratory rate monitoring system (hrrm).The bed exit alert feature 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).The hrrm system is intended to aid in the evaluation process of a patient¿s clinical status and should be interpreted by a healthcare practitioner only and is designed to provide continuous and contact-free measurement of heart and respiration rate with the use of the heart rate/ respiratory rate monitoring sensor.The system sounds an alarm to notify the caregiver when the patient¿s heart rate or respiratory rate, averaged over time, passes above or below the user-defined limits or thresholds.The device ifu states the monitoring system is not intended for monitoring high-risk situations where ecg monitoring is required.The most reliable method of patient monitoring combines close personal surveillance with correct operation of the monitoring equipment.Additionally, heart and respiration rate values are most likely to show when the patient is laying centered in the bed, with the angle of the bed¿s head section as low as clinically appropriate.The bed's exit alert will have priority over a heart rate or respiration rate alarm.The user must address the bed exit alert before the heart rate or respiration rate alarm will show on the touchscreen.An inspection of the bed by a hillrom technician found the bed and its components to be working as designed.The technician noted that the bed had no active error logs, the exit alarm functioned appropriately including its voice and audible alarms.In this event, the patient sustained a fall with injuries (forehead indentation, rib bruising, skin tear) and transfer to higher level of care.Due to the sparsity of information, it is unclear whether the injuries from the fall or the patient¿s medical condition prompted the transfer.The patient subsequently died, with the cause of death reported to be a gi bleed, likely due to the patient¿s relevant medical history prior to the fall (colon cancer, near syncope and gi bleed).The exact severity of the patient¿s injuries prior to death is unable to be determined due to radiology imaging reported as ¿attempted,¿ with no conclusions reported to evaluate if internal trauma was sustained by the patient.However, despite lack of radiology imaging results, based on the description of the patient¿s injuries, it can be reasonably concluded that the patient¿s fall event with head trauma and loss of consciousness would be considered a serious injury.Additionally, the customer reported the third-party nurse call system was not connected to the centrella bed at the time of the event, the bed exit alarm was reported to be heard from the room by the caregiver, and inspection found no malfunction of the bed or components.Therefore, it is unlikely based on this information, that a malfunction or defect of the device caused or contributed to the patient¿s fall/death.It is likely that use error (bed not being connected to the customer¿s third-party nurse call system) contributed to the serious injury.The death was likely related to the patient¿s underlying medical condition (gi bleed) and not related to the use of the centrella bed.Based on this information, no further action is required.
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