Model Number MCP00703309 |
Device Problems
Device Displays Incorrect Message (2591); Unintended Movement (3026)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/03/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).
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Event Description
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As stated by the field service technician: ""i faced a problem which is related to rpm drive.After turning on the rpm drive, without any other action, the pump suddenly starts to rotate very fast and s-stop error is seen and the pump stops." no patient involvement.(b)(4).
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Manufacturer Narrative
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Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).As stated by the field service technician the issue could be solved by replacing the motor control board.Despite several requests further information about service documents and part return have not been received.Thus no investigation could be performed.The root cause could not be determined.The failure could not be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.
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Event Description
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Internal reference: (b)(4).
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Search Alerts/Recalls
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