Other, other text: b3: date of event 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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Evaluation codes: updated.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.The exact cause could not be determined; however, based on the reported problem, the most probable cause would be the setting of the over temp alarm potentiometer on the pcb was out of range.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.If the product is returned, the manufacturer will reopen this complaint for further investigation., corrected data: d3, g1, and g2 email is: (b)(6).
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