Other text: b3: date of event is unknown, no information has been provided to date.A product sample was received and is awaiting evaluation, 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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Other text: h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.One device was received.Per visual inspection, corroded drain fitting, cracked tank cover, and worn plate clip.Per functional testing, the pump was noisy when running.The complaint was confirmed.The root cause was a faulty pump.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 pump, drain fitting, tank cover, and plate clip.Performed preventative maintenance (pm).The device passed all functional and delivery tests.
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