Model Number 95161-000 |
Device Problems
Device Reprocessing Problem (1091); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/15/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The service technician replaced the level sensor to resolve the issue.The removed level sensor was returned to medtronic.Laboratory analysis of the component could not conclusively determine the type of water that had been used in the bio cal.Medtronic received additional information indicating that the ice used in the instrument is derived from tap water.Bleach is run through the bio cal as part of the cleaning process.Per the operator's manual, tap water and bleach should not be used in the bio cal.
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Event Description
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Medtronic received information that during setup, the customer observed that the bio cal instrument was exhibiting high current leakage.The instrument was replaced with a backup and there was no resulting adverse patient effect.The facility biomed determined that the current drain was related to the heating element and requested field service.Medtronic received additional information indicating that the ice used in the instrument is derived from tap water.Also, bleach is run through the bio cal as part of the cleaning process.
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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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