During shift checks, the autopulse platform (sn (b)(6)) keeps displaying user advisory (ua) 45 (not at "home" position after power-on/restart).The customer attempted to clear the advisory message by returning the driveshaft to "home" position, following the administrative menu more than once.However, the ua45 appears again the day after it is cleared.No patient involvement.
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D9 (returned to manufacturer) was updated.H4 (device manufacture date) was updated.The reported complaint that the autopulse platform (sn (b)(6)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) was confirmed in the archive data and during functional testing.The root cause of the ua45 advisory message was that the driveshaft was not in "home" position, most likely attributed to unintended user error.Upon visual inspection, no physical damage was observed.The archive data review indicated multiple ua45 advisory messages around the reported event date, confirming the customer's reported complaint.A user advisory is normally a clearable error message, and it is designed into the autopulse platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse® resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45), pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.Preliminary functional test failed as the autopulse platform displayed a ua45 advisory message upon powering up, confirming the reported complaint.The driveshaft was rotated to "home" position to remedy the ua45 advisory message.Subsequently, the autopulse platform successfully passed multiple run-in tests.Zoll is awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with serial number (b)(6).
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