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(b)(4).On (b)(6) 2018 arjo was informed of the event, which occurred in (b)(6) medical center in (b)(6) (us).Based on the customer allegation, the patient fell off the enterprise 9000x bed and the exit alarm was not activated.Based on the information provided by the facility, the patient sustained injury, however more details were not available.After this event, the involved device was withdrawn from use and inspected by the facility maintenance staff.No failure with the bed, nor the alarm was detected.The event was not declared to arjo at this time.One week later, the nurse could not set the alarm, therefore the bed was taken out of use again.Then, arjo was notified about the issue and the arjo technician visited the facility.The evaluation revealed that the device was in generally good condition with no obvious faults identified.All the bed's functions (including exit alarm) were working as intended.All manufactured enterprise 9000x beds are checked before being distributed to the customers to verify if the product meets the required manufacturer's specifications and check whether the acceptance criteria are met.Records of the inspection are documented in the device history record (dhr).The device history record has been reviewed for the involved device with the serial number (b)(4) and no anomaly was found.Following the limited information provided by the facility staff, the circumstances of the event could not be clearly determined.There was not possible to confirm, whether the safety sides were raised during the event and there were no details regarding the involved patient available.The product instructions for use (#746.591-en-1 dated on aug 2013) which was supplied together with the involved bed contains all crucial information and warnings which should be followed to ensure patient safety: "to reduce the risk of injury due to falls, lower the bed to minimum height when the patient is unattended"."to ensure the patient can use the bed safely, their age and condition should be assessed by a clinically qualified person"."ensure that the locking mechanism is securely engaged when the split side rails are raised".If the recommendations mentioned above are followed up by the end user, the risk of any hazardous situation is minimized.In the light of the information gathered through the device evaluation and communication with the facility staff, the cause of the event cannot be clearly confirmed.It should be pointed out that no malfunction within the bed was detected after the event, what confirms that the manufacturing or another device error can be ruled out as a contributing factor.Additionally, the customer allegation indicated that the exit alarm was not activated during the event, however the alarm malfunction was not confirmed during the inspection.It is probable that the alarm was not used in accordance with instruction for use, therefore the re-training for the facility staff will be conducted.When reviewing similar reportable events registered in the last five years for enterprise range, arjo has found a limited number of cases related to the same or a similar scenario.In conclusion, the enterprise 9000x bed was being used for patient care at the time of the event.There was no product malfunction found within the device and from that perspective, it was assumed that at the time the patient's slipped out of the device the bed was working up to manufacturer's specification.The complaint decided to be reportable due to the allegation of patient's fall and the injury sustained.
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On 15 nov 2018 arjo was informed of the event, which occurred in (b)(6) medical center in (b)(6) (us).Based on the customer allegation, the patient fell off the enterprise 9000x bed and the exit alarm was not activated.Based on the information provided by the facility, the patient sustained injury, however more details were not available.After this event, the involved device was withdrawn from use and inspected by the facility maintenance staff.No failure with the bed, nor the alarm was detected.The event was not declared to arjo at this time.One week later, the nurse could not set the alarm, therefore the bed was taken out of use again.Then, arjo was notified about the issue and the arjo technician visited the facility.The evaluation revealed that the device was in generally good condition with no obvious faults identified.All the bed's functions (including exit alarm) were working as intended.
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