It was reported that during patient use on a (b)(6) cardiac arrest patient, the autopulse platform displayed a user advisory (ua) 18 (max take-up revolutions exceeded) message.The user extended the lifeband to its maximum positon, but the lifeband was unable to retract.The user reverted to manual cpr (exact length of time was not provided).The patient subsequently expired.No further information was provided.Manufacturer has made several attempts to obtain additional information from the customer, however no additional details have been obtained.
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The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection was performed and no physical damages were observed.A review of the platform's archive data was performed and found multiple user advisory (ua) 18 (max take-up revolutions exceeded) messages on the reported event date of (b)(6) 2015.Per autopulse® maintenance guide (p/n 11653-001), ua18 is exhibited when the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.At the time that this ua was exhibited, there was no recorded load change.The customer's reported complaint was not duplicated during functional testing.The platform passed a load cell characterization test, which confirmed that both load cells were functioning within specification.After load cell characterization testing, the platform ran with a 95% patient test fixture (lrtf) for several hours with no issues observed.The autopulse passed all testing requirements.No device deficiencies were found with the platform that may have been contributory to the ua 18.A root cause could not be determined.Based on the investigation, the parts identified for replacement were the front and bottom covers and the clutch plate.In summary, the customer's reported complaint that the platform displayed a user advisory 18 message was confirmed during review of the platform's archive data.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to the reported event.The platform passed load cell characterization testing, which confirmed that both load cells were functioning within specification.The platform passed all final functional testing criteria.Based on the information received from the customer, the crew reverted to manual cpr, after the platform displayed a user advisory (ua) 18 message, which is a standard of care.Autopulse is adjunct to manual cpr.In case of stoppage of autopulse the user reverts to manual cpr.The patient's death is likely attributed to the patient's condition of cardiac arrest.
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