B3: date of event and d4: udi number is unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr, 803.56, when additional reportable information becomes available.
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Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: (b)(6).One device was received.Per visual inspection, the water tank cover was cracked, pump was not working, front cover chipped.Per functional testing, the device was leaking from the bottom left side of the water tank cover and the device was out of calibration causing the high temperature alarm.The root cause was a cracked water tank cover and pump was not working.It was unknown what caused the condition.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.Replaced the water tank cover and the pump, front cover.Replaced o-rings, reservoir gasket for preventative maintenance (pm) and calibrated.The device passed all functional and delivery tests.
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