Model Number 95161-000 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic requested additional information regarding the water sources and cleaning protocols the facility was using with the bio cal, but no response was received.
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Event Description
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Medtronic received information that during set up prior to use this bio cal instrument displayed a water level error.The instrument was replaced with a backup instrument.There was no patient involvement in the event.The customer was provided with the part number to order a replacement water level sensor and stated that they would perform the repair at their facility.Medtronic requested additional information regarding the water sources and cleaning protocols the facility was using with the bio cal, but no response was received.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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