It was initially reported that on (b)(6) 2014, the bottom lower housing of the autopulse platform has some cracks and a noise was coming from inside the platform, indicating that there is loose hardware inside the device.The platform is still functional.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the autopulse platform displayed a user advisory (ua) 27 (encoder fault (>3000 rpm)) message.Additionally, during review of the platform's archive data, it was observed that a user advisory 18 (max take-up revolutions exceeded) message occurred on the reported event date of (b)(6) 2014.Although the customer did not report this, ua 18 and 27 are considered reportable malfunctions.
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The autopulse platform in complaint was returned to zoll on 12/2/2014 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found that the front enclosure, motor cover and top cover were damaged.The platform underwent initial functional testing using an lrtf (large resuscitation test fixture, equivalent to a 250 pound patient) and within 30 seconds the platform displayed a user advisory (ua) 27 (encoder fault (>3000 rpm)) message.A review of the archive was performed which found that a ua18 (max take-up revolutions exceeded) occurred on the reported event date of (b)(6) 2014.Multiple ua 27's were also observed throughout the archive.The front enclosure, motor cover and top cover were replaced to remedy the reported complaint.Additional work performed to ensure that the autopulse platform is functioning without issue: lcd and load cell amp cable and the encoder gearbox were all replaced.The platform underwent and passed all final functional testing.The customer's reported complaint of the platform having cracks on the bottom of the housing and something being loose inside was confirmed through visual inspection of the returned platform.The encoder gearbox was replaced to remedy the user advisory 18 and 27 faults found in the archive.
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