It was reported that during use on a mannequin, the autopulse platform displayed a "realign patient/mannequin" message.Customer indicated that the platform did not properly perform take-up of the autopulse lifeband.The lifeband did not take-up equal slack in the bands (more slack from one side of the band is taken up compared to the other side).After the message displayed on the platform, customer checked the alignment of the mannequin but the issue did not resolve.Customer indicated that they used the same mannequin on other platforms and did not encounter any issues.No patient involvement was reported.No further information was provided.
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Investigation results for the returned platform are as follows: visual inspection of the returned platform was performed and found that both patient head restraint brackets were cracked.The physical damages found during visual inspection are unrelated to the customer's reported complaint of the platform displaying a "realign patient" message.A review of the platform's archive data was performed and revealed that the archive data was partially corrupted.Data on and around the reported event date of (b)(4) 2015 could not be retrieved.Therefore, the customer's reported complaint could not be confirmed through review of the platform's archive data.The customer's reported complaint that the platform did not properly perform take-up of the autopulse platform was confirmed when a user advisory (ua) 18 (max take-up revolutions exceeded) message displayed within the first compression.The platform failed initial functional testing due to the ua 18 message.A load cell characterization test was performed, which confirmed that both load cell modules were defective and under-reporting values.It should be noted that a ua 18 requires users to pull up on the lifeband and check patient alignment.Based on the investigation, the parts identified for replacement were both load cell modules and both patient head restraint brackets.In summary, the customer's reported complaint was confirmed during functional testing when the platform displayed a ua 18 message within the first compression.It should be noted that a ua 18 requires users to pull up on the lifeband and check patient alignment.The root cause of the ua 18 was determined to be defective load cells.The physical damages found during visual inspection are unrelated to the customer's reported complaint.The autopulse is a reusable device and therefore, these types of physical damage can occur due to normal wear and tear and/or physical abuse.
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