Other, other text: 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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One device was received very dirty.Per visual inspection line cord discolored, quick connect corroded, pole clamp discolored, printed circuit board (pcb) was missing a light emitting diode (led), microswitch and main block damaged, enclosure and front cover were scratched and had nicks in them.Per functional testing, the device was over temping confirming the complaint.The root cause was an inoperative water pump no longer recirculating water.It was unknown what caused it to become inoperative.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.No action taken due to the condition of the device.It was deemed beyond economical repair and was scrapped.
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