The autopulse platform in complaint was returned to zoll (b)(4) on (b)(6) 2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.Please note that zoll (b)(4) received an initial call on (b)(6) 2015 from the distributor about a device return.At that time, details of the malfunction was not reported by them.The platform arrived at zoll (b)(4) on (b)(6) 2015 without knowledge of any complaint.Information regarding the event was reported to zoll (b)(4) on (b)(6) 2015.
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Investigation results for the returned platform as follows: visual inspection of the returned platform was performed and found no visible or physical damages to the platform.A review of the platform's archive data was performed and found that a user advisory (ua) 2 (compression tracking error) message occurred on the reported event date of (b)(6) 2015, thus confirming the customer's reported complaint of a ua 2 message.The reported complaint that the autopulse platform stopped, made a noise when the autopulse lifeband adjusted to the mannequin's chest and displayed a ua 2 message was duplicated during functional testing.Further inspection of the device revealed that the load cell amp cable was not connected properly because the connector on the processor pca board that connects to the load cell amp cable was damaged.Because the load cell amp cable was not connected, pressure was applied to the load cell before "take up" of the lifeband was completed, thus resulting in a ua 2 message.Based on the investigation, the part identified for replacement was the processor pca board.After replacement of the processor pca board, it was observed that the shape of the load cell amp cable was different so the cable was also replaced.In summary, the customer's reported complaint that the autopulse platform stopped, made a noise when the autopulse lifeband adjusted to the mannequin's chest and displayed a ua 2 message was confirmed during review of the platform's archive data and also duplicated during functional testing.The root cause was determined to be a damaged connector on the processor pca board.After replacement of the processor pca board and the load cell amp cable, the platform passed all final functional testing criteria.
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