Per the fda letter regarding report nol mw5034337, received by arjohuntleigh on (b)(6) 2014, the customer reported the rotoprone bed was not working properly.As the pt was supine, rotation therapy was started.Limits were set at 45 degrees for left and right rotation.Bed rotated pt greater than 60 degrees and pt almost fell out of the bed.Nurses had to hold pt in the bed while the cpr button at the computer site was pushed to bring the pt back down to 0 degrees supine.Also, bed would not allow proper functioning during normal therapy settings.There was no injury reported due to this event.Arjohuntleigh is reporting this event with an abundance of caution as if this type of event were to recur, it may cause or contribute to death, serious injury or medical intervention to prevent harm.
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This report is being filed by the manufacturer arjohuntleigh, inc.Please note that previous medwatch reports for this product may have been submitted from the manufacturing site kinetic concepts, inc.As of (b)(4) 2012, complaints related to this product are to be handled by arjohuntleigh, inc.This report is being filed late due to lack of the arjohuntleigh complaints dept.The complaint process regarding field employees is being reviewed and will be addressed in a supplemental report.Add'l info will be provided upon conclusion of the manufacturer investigation.
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