Model Number 9625A21CON6614 |
Device Problem
Delayed Alarm (1011)
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Patient Problem
Fall (1848)
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Event Date 11/03/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is in progress.The conclusions will be provided within the follow up report once the investigation is completed.
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Event Description
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Following the information provided the customer complained that the exit alarm activated with a delay.After the activation of exit alarm, the nurses went to the room and found the patient lying on the floor.There is no indication of any injury sustained.The evaluation of the bed performed after the event confirmed that the bed was working in accordance to the specification, no malfunction was detected.
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Event Description
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Following the information provided the patient fell from the enterprise 9000x bed.There is no indication of any injury sustained.There was an allegation that the exit alarm activated with a delay.After the activation of the exit alarm, the nurses went to the room and found the patient lying on the floor.The bed egress alarm allegedly activated with a delay when the incident occurred, but it could not be confirmed during the bed inspection.The weighting scale and the varizone patient movement detection system (which can be set to alarm when undesired movement of the patient occurs) were tested and no abnormality was found.
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Manufacturer Narrative
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Based on the review of post-market surveillance data and an arjo service manager's assessment, the bed was deemed working as intended and there was no fault found.The device was used for patient treatment when the event occurred.No malfunction was found on the device and it was working as intended.This complaint is deemed reportable due to alleged patient's fall from the bed.
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Search Alerts/Recalls
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