Model Number 48-30-00 |
Device Problems
Device Alarm System (1012); Pumping Stopped (1503)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/08/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was not provided.Livanova (b)(4) manufactures the s5 system.The incident occurred in (b)(6).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.
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Event Description
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Livanova (b)(4) received a report that a s5 system alarmed without warning massages and that a pump stopped during procedure.There was no report of patient injury.
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Manufacturer Narrative
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Through further provided information livanova deutschland determined that the reported issue will now considered as not reportable.As a pump stop which was initiated on purpose during a demonstration/training and a following error which was not displayed on the central display is not likely to result in death or serious injury.
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Event Description
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See initial.
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Search Alerts/Recalls
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