Model Number 10-80-00 |
Device Problem
No Display/Image (1183)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/20/2015 |
Event Type
No Answer Provided
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Manufacturer Narrative
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There was no patient involvement.Device has not been returned to sorin group deutschland.Sorin group (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin (b)(4).Sorin (b)(4) received a report that the touch screen of the s5 roller pump became unresponsive during priming.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.
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Event Description
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Sorin group (b)(4) received a report that the touch screen of the s5 roller pump became unresponsive during priming.There was no patient involvement.
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Manufacturer Narrative
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Livanova (b)(4) manufactures the s5 system.The incident occurred in.This medwatch report is being filed on behalf of livanova (b)(4).A livanova field service representative was dispatched to the facility for investigation.The field service representative confirmed the complaint.The touchscreen was replaced to resolve the reported issue.Nvmem was cleared on new touchscreen, pump settings were re-installed, and the unit was returned to service.A review of the dhr did not identify any deviations or nonconformities relevant to the reported issue.Evaluated on site by livanova rep.
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Search Alerts/Recalls
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