ARJOHUNTLEIGH, A BRANCH OF ARJO LTD MED AB AUTO LOGIC; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
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Model Number 630004FR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fall (1848); Injury (2348)
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Event Date 10/09/2020 |
Event Type
Injury
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Manufacturer Narrative
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Please note that previous medwatch reports for this product may have been submitted under the following registration numbers: (b)(4).Currently, these products are to be handled by (b)(4) complaint handling establishment, and any medwatch reports will be submitted under registration (b)(4).An investigation is ongoing, conclusions will be provided to the follow-up report.
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Event Description
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Arjo was informed about a patient fall from a bed when was on an auto logic mattress (arjo product), and an unknown bed.According to information reported by a customer, the patient fell when she was trying to go to the bedroom.The patient was found conscious laying on the floor.A wound on the left eyebrow arch has been reported as outcome of the reported event.It is unknown if a medical intervention was needed.
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Manufacturer Narrative
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Corrected following data: describe event as it was clarified that the involved bed was no arjo product.Updated model and serial number of the involved pump (initially provided information was related to mattress).Manufacturer narrative: arjo was informed about a patient fall from a bed when was on an auto logic mattress (arjo product) and an hill rom bed (no arjo product).The patient was found conscious laying on the floor.A wound on the left eyebrow arch was reported as outcome of the reported event.No medical intervention was needed.An investigation was conducted to establish a root cause of the reported issue.According to information reported by a customer, the patient fell when she was trying to go to a bathroom, the safety sides were not used at time of the event.The decision to use side rails is to be decided according to internal facility protocol.According to instruction for use (654900en_01) ¿whilst the patient is unattended, safety sides should be used based on clinical assessment and in line with local policy.¿ to conclude, the arjo auto logic system (both mattress and pump) was used while the event occurred, therefore it played a role in the event.There was no issue with the arjo device.The safety sides were not used at time of the event.The complaint was assessed as reportable due to allegation of patient fall, which may lead to serious health consequences.
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Event Description
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Arjo was informed about a patient fall from a bed when was on an auto logic mattress (arjo product) and an hill rom bed (no arjo product).The patient was found conscious laying on the floor.A wound on the left eyebrow arch was reported as outcome of the reported event.No medical intervention was needed.
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Search Alerts/Recalls
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