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(b)(4).On (b)(6) 2017 arjohuntleigh was initially notified about an incident involving enterprise 9000 bed.The reported malfunction took place in (b)(6) in the united states.No injury nor other medical consequences were reported.Following information reported by facility director of patient transport on (b)(6) 2017 when the customer facility stuff plugged our beds into the red "emergency" outlets in the rooms, the bed reverted to a backup battery mode and in 45 minutes to an hour, the battery was discharged.He also stated that when they plugged the same beds into the white "regular" wall sockets, they worked fine.The same day arjohuntleigh technician was informed by supervisor of patient transport and resident bed expert that a patient had fallen from a bed.Due to the fact the battery was discharged the exit detection alarm did not sound and the nursing staff was not alerted to the patient being off the bed.Arjohuntleigh technician noted that he had always been told not to plug beds into the red outlets.They are backed up by generators, and whenever they are tested, there could be surges in power which could damage a bed.Moreover if an outlet put out less than the minimum amount of voltage, the bed will revert to its battery.On (b)(6) 2017 arjohuntleigh representative left the director of patient transport an invoice mail informing about all above and asked for details regarding patient's fall, but he never called back.On 2017-dec-21 arjohuntleigh representative received a call from person from a purchasing department, saying that they need someone on site.Taking advantage of the opportunity the arjohuntleigh representative asked him for details regarding patient's fall, e.G.If the patient was hurt, what unit was involved in the incident etc., unfortunately no response was provided.According to the incident description form (idf) arjohuntleigh was informed by customer facility representative that a person fell out of an enterprise 9000 bed.The hospital did not create a service work order for that bed nor did they isolate this particular device.The bed was reportedly put back into service.On 2017-dec-28 the third attempt was made to gather additional information regarding patient's fall, however without success.The customer facility staff did not provide any further clarification about alleged patient's fall.Despite multiple attempts to gather information from customer facility, we have not received any additional details regarding the reported incident.Since the bed involved in the incident was not isolated and it could not be confirmed which exactly bed was involved, the decision was made by arjohuntleigh representative and the director of patient transport to inspect every enterprise bed on the floor where the incident occurred.There were 10 enterprise beds found in use by patients and 1 enterprise bed being left in the hallway not used with patient.All the checked beds were in good condition with no modifications found.Of the 10 beds that were being used by patients 8 beds did not present any deficiencies and were functioning as intended.Two of the beds had some issues not related to the incident.The bed found on the hallway had a loose power cord connection to the bed.It was determined by arjohuntleigh technician and the customer facility representatives checking the beds that the loose power cord connection could be the root cause of the incident.Although it remind unknown if this is the bed that the patient fell out of (since the bed was not isolated by the customer facility staff) it would explain why the exit detection alarm did not sound.It needs to be emphasized that not working exit detection alarm itself does not lead to patient's fall, it alarms only when undesired movement of the patient occurs.The sensitivity of patient movement detection relative to the center of the deck.According to arjohuntleigh technician's opinion the power cord could have been jarred loose when kicked accidently or the bed could have been moved without unplugging it first.The bed could appear to be plugged into the power cord while was actually running on backup battery leading to battery discharge and exit alarm disfunction.The exit alarm would not work without a good connection of the power cord while the battery is discharged.The arjohuntleigh technician educated the customer facility staff how to properly connect power cord and informed about the functionality of battery of the bed and its replacement schedules (every 2 years).To prevent from patient's falling the product instruction for use (#746.579 rev.04 dated on may-2015) contains the following information and warnings : "to reduce the risk of injury due to falls, leave the bed at minimum height when patient is unattended", "side rails must only be used with a mattress of the correct size and which is approved for use with the bed", "the decision to use side rails must be made by the clinician(s) overseeing the case of the individual patient, and within the framework of the individual patient assessment in ensuring a safe bed environment".The minimum level of preventive maintenance recommended by manufacturer assumes: "ask a person to lie on the bed and turn varizone patient movement detection system.Check that when the person gets off the bed, the patient movement alarm is triggered"(once a year), "check operation of side rails" (weekly).Unfortunately despite our best efforts we did not receive information if the safety sides securing the patient from falling were raised while the incident occurred.It remind unknown neither if the fall was witnessed nor if the patient fell from bed while trying to leave the device.Moreover we were not informed what mattress was used with the bed involved in patient's fall to determine if it's size was adequate.The review of the previous complaints related to patient's falls from bed showed that the root cause of these failures can be related to following errors of use: - safety sides left in lowered position with patient on bed, - patient exiting the bed while being unattended, - too high mattress (patient exiting the bed from above the safety sides), because of the very limited information collected, none of these causes can be confirmed in this case.In summary, although no patient's injury was reported the complaint was decided to be reportable based on a potential due to the risk of serious injury upon patient's fall recurrence.The device was being used for patient care at the time of the incident.Because of the very limited information collected, we were unable to determine the exact root cause of the issue occurrence.Moreover as the serial number of reported bed remind unknown we were not able to establish if at the time the incident occurred the enterprise 9000 bed was working up to the manufacturer's specification.
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On (b)(6) 2017 arjohuntleigh was initially notified about incident involving enterprise 9000 bed.The reported malfunction took place in (b)(6) in the united states.No injury nor other medical consequences were reported.Following information reported on (b)(6) 2017 the director of patient transport informed arjohuntleigh representative that when they plugs our beds into the red "emergency" outlets in the rooms, the bed reverts to a backup battery mode and in 45 minutes to an hour, the battery is dead.He also stated that when they plug the same beds into the white "regular" wall sockets, they work fine.The same day arjohuntleigh technician was informed by supervisor of patient transport and resident bed expert that a patient had fallen from a bed.
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