Other, other text: b3: date of event and d4: udi section are 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 evaluation: one device was retuned for investigation.Visual inspection noted: device received with an enclosure that had dents in it, front cover dented, water tank cover cracked, lcd broken, quick connect corroded, line cord faded and worn, and the microswitch was bent.Inspectors could visually observe that the lcd was unreadable due to damage.Functional testing found the pump was not circulating, confirming the customer complaint.The cracked lcd display showed ink leakage from impact damage.Root cause was attributed to customer impact damage.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 is deemed beyond economical repair and will be scrapped.
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