Model Number ROTAFLOW |
Device Problems
No Audible Alarm (1019); Device Displays Incorrect Message (2591)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/14/2019 |
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).Device evaluated by mfr: device not returned, not evaluated.
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Event Description
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During patient treatment the pump did not work without an error message.No harm to the patient was reported.Complaint# (b)(4).
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Manufacturer Narrative
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The rotaflow drive was investigated from emtec service technician with the service order report# rma2019-10139 and order# 300366878 on the 2019-04-05: the described failure of the customer could be confirmed.The speedometer disc broke due to touching or grinding the hedl (end coding module), but the speedometer disc was not loose on the shaft.Therefore the speedometer was exchanged.Root cause unknown.The device was also investigated from the getinge service technician with the service order report# 10477609 and customer order# :rma# 38319 on the 2019-06-28: problem description: defective tacho strobe was exchanged.Rotaflow has passed all tests see also the service protocol.
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Event Description
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Complaint# (b)(4).
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Search Alerts/Recalls
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