Model Number 10-88-00 |
Device Problem
Detachment Of Device Component (1104)
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Patient Problem
No Patient Involvement (2645)
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Event Date 07/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(4).This medwatch report is being filed on behalf of (b)(4).If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Pump cover scrapped by customer.
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Event Description
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(b)(4) received a report that a magnet fell out of the s5 mast roller pump cover during setup.There was no patient involvement.
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Manufacturer Narrative
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(b)(4) manufactures the s5 mast roller pump.The incident occurred in (b)(6).A livanova field service representative replaced the s5 mast roller pump cover and subsequent testing found no further issues.A technical inspection was performed successfully and the device was returned to service.A review of the dhr did not identify any deviations or non-conformities relevant to the issue.Corrective actions are in progress for this issue.Evaluated on site by livanova technician.
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Search Alerts/Recalls
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