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The customer reported that a patient exited the versacare bed, the patient fell and subsequently expired.During a follow-up call with the customer, the customer reported that a bed exit alert was generated from the bed, enunciated at the bedside, and communicated via the nurse call system, from the patient¿s room around ¿midnight.¿ this alert was attended to by a caregiver at that time, then at approximately 3:45 am, an unwitnessed fall occurred in the patient¿s room, and the bed nor the nurse call system provided a bed exit alert.At this time, a code blue was initiated via the nurse call system which was received and responded to by caregivers.The customer reported that the patient subsequently expired on the same day of the event.The customer declined to provide the patient¿s determined cause of death or any further patient information.It is noted that this patient was reported to have been ¿confused¿ and considered a ¿high fall risk.¿ this evaluation is associated with the allegation related to the versacare bed, the allegation of related to the nurse call system will be addressed in complaint (b)(4).This report was filed in our complaint handling system as complaint (b)(4).
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The customer reported that a patient exited the versacare bed, the patient fell and subsequently expired.During a follow-up call with the customer, the customer reported that a bed exit alert was generated from the bed, enunciated at the bedside, and communicated via the nurse call system, from the patient¿s room around ¿midnight.¿ this alert was attended to by a caregiver at that time, then at approximately 3:45 am, an unwitnessed fall occurred in the patient¿s room, and the bed nor the nurse call system provided a bed exit alert.At this time, a code blue was initiated via the nurse call system which was received and responded to by caregivers.The customer reported that the patient subsequently expired on the same day of the event.The customer declined to provide the patient¿s determined cause of death or any further patient information.It is noted that this patient was reported to have been ¿confused¿ and considered a ¿high fall risk.¿ this evaluation is associated with the allegation related to the versacare bed, the allegation of related to the nurse call system will be addressed in complaint (b)(4).The versacare bed is intended to provide patient support suited to be used in healthcare environments.The versacare bed may be used in such settings as acute care, step-down/progressive care, medical/surgical, high acuity sub-acute care, post-anesthesia care unit (pacu), and sections of the emergency department (ed).The versacre¿s bed exit alarm system provides an audible and visual alert notification to the caregiver team.However, it is not intended as a substitute for good nursing practices.The device ifu states that the bed exit alarm system must be used in conjunction with a sound risk assessment and protocol.The bed¿s exit alarm control is located on the flip-up control pod on the outside of the head-end siderails and features indicator icons for the patient exiting positioning mode selected by the caregiver.When the bed exit is on, the selected positioning icon is illuminated.The ifu provides states the following for setting the bed's exit alarm: the bed exit alarm system control is located on the flip-up control pod on the outside of the head-end.1.) zero the bed exit feature, 2.) make sure the bed is plugged into ac power; 3.) make sure the patient is centered on the bed and aligned with the hip locator, 4.) press the enable control until the indicator illuminates.5.) press the desired mode control.When the system beeps one time and the indicator stays on solid, the system is armed.Additionally, the ifu states that "if the system does not arm, the system will beep rapidly for a few seconds and the selected mode indicator will flash.This means: the patient's weight is outside of these ranges: a model¿70 lb to 500 lb (31.8 kg to 227 kg) b through j models¿50 lb to 500 lb (23 kg to 227 kg), the patient is not in the correct position, or the system has malfunctioned.The bed exit alarm system does not operate on battery back-up.An initial inspection of the bed performed by the customer, found the bed to be functioning as designed.An additional inspection performed by a baxter technician accompanied by the customer¿s biomed representative, of the bed, its components, and its functionality with the nurse call system found the bed to be working as designed.Furthermore, a review of the log files indicates there was no malfunction of the bed at the time of the reported events, and that the user silenced and deactivated the bed¿s exit alarm at the time of the initial bed exit alert notification (midnight), thus preventing an alert from being generated by the bed¿s exit alert function at the time of the second event (3:45 am).In this event, a bed exit alert was not enunciated, an unwitnessed fall occurred, and the patient subsequently expired.It is unknown if the fall caused or contributed to the patient¿s death.The device inspection and a review of the event call logs indicate that there was no malfunction of the bed.The root cause of the event (failure of bed exit alert) is due to use error (deactivation of exit alarm and failure to reactivate) and is not related to a malfunction of the versacare bed.
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