Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.B3 unknown, d3, g1, and g2 email is:(b)(6).
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Other, other text: one device was returned for analysis.Visual inspection showed a cracked dso seal, worn uso seal, and scratched lens.The pump did not power on.The tamper seal was broken.The ehl was unable to be downloaded.A functional test was performed and the reported issue was duplicated.When powering up, the device displayed a constant alarm.The cause was due to the pwa board.As a result, the pwa board was replaced.A service history review identified there was no indication that the complaint was related to a service of the device within the review period.D3, g1, and g2 email is: regulatory.Responses@icumed.Com.
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