It was initially reported that the autopulse platform's case was cracked down by the battery compartment.Customer indicated that the platform was not dropped.No adverse patient sequelae was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During review of the platform's archive data, it was observed that a user advisory (ua) 18 (max take-up revolutions exceeded) message occurred on the reported event date of (b)(6) 2015.Although the customer did not report this, ua 18 is considered a reportable malfunction.
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The autopulse platform in complaint was returned to zoll on 03/05/2015 for investigation.Investigation results as follows: visual inspection was performed and the initial reported issue of the platform being cracked in the area of the battery compartment could not be confirmed.However, the following damages were observed: the screw on the motor cover was missing, the battery partition at the battery compartment was missing and the front encoder and motor covers were damaged.From the condition of the platform, the damages appear to have been due to wear and tear.The platform was functionally tested for 15 minutes with a test manikin and no issues were observed.The platform performed as intended during functional testing.Unrelated to the initial reported complaint, a user advisory (ua) 18 (max take-up revolutions exceeded) was observed on the reported event date.Based on the platform's archive data, the ua 18 code occurred as a result of no load change detected at the load plate due to no object being placed on the platform.Based on the investigation, the parts identified for replacement were the front encoder cover, motor cover including screws and the missing battery partition.In summary, the initial reported complaint of the platform being cracked in the area of the battery compartment was not verified; however, other damages were observed.The damages observed were attributed to wear and tear.Unrelated to the event, a ua 18 was seen on the reported event date and attributed to no load placed on the platform.Following service, including replacement of the damaged parts, the device passed all testing criteria.
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