The reported complaint of the autopulse platform stopped compressions after 2-3 minutes and system error, out of service, revert to manual cpr displayed was not confirmed during functional testing.The second customer complaint for the platform displayed user advisory (ua) 45 (not at "home" position after power-on/restart) upon powering on the platform was also not confirmed during functional testing.The autopulse underwent functional testing with a large mannequin fixture (equivalent to 250 pounds patient) for 19 minutes and for 5 minutes using test manikin.The platform passed functional testing with no fault.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to user advisory (ua) 17 (max motor on time exceeded) and user advisory (ua) 45 error message.In addition, during the evaluation, user advisory (ua) 12 (lifeband not present) was observed intermittently and the sticky clutch plate was noted, unrelated to the reported complaint.Switch belt assembly was adjusted and clutch plate was deburred to remedy the issue.The autopulse passed all the testing and met all required specifications.A review of the autopulse's archive was performed and it shows user advisory (ua) 17 and user advisory (ua) 45 to have occurred, thus confirming the reported complaint.The archive also shows user advisory (ua) 12 to have occurred but it's unrelated to the reported complaint.The platform stopped performing compression due to user advisory (ua) 17.The root cause was due to the platform not reaching the target depth within specification due to the stiff patient.User advisory (ua) 45 error message alerts the operator that the autopulse driveshaft is not at its home position when the platform was powered on.Per the autopulse user guide instruction, to clear ua 45 error message, the operator needs to pull up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.User advisory (ua) 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The most likely cause of the platform exhibiting ua12 was determined to have been movement of the patient & platform, causing the lifeband to become detached from the platform.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint for autopulse sn (b)(4), reported under ccr (b)(4).The complaint was reported on (b)(6) 2017.The platform stopped performing compression due to user advisory (ua) 17 (max motor on time exceeded).The root cause was due to the platform not reaching the target depth within specification due to the stiff patient and the low voltage battery used during the event.
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During patient use, customer reported that the autopulse platform stopped compressions after 2-3 minutes of operation and displayed "system error, out of service, revert to manual cpr".The crew immediately switched to manual cpr.There was no report of patient consequence as a result of the reported issue.The customer reported 2 separate events involving same platform.Date of event is unknown.This complaint is for the second event occurred during the patient use.For the first event see mfr: 3010617000-2018-00500.
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