Model Number 61000 |
Device Problems
Inadequate User Interface (2958); Data Problem (3196)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/07/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: this issue was identified during an internal evaluation of available run data files.No on-site service was performed.One year of service history was reviewed for this device with no issues related to the reported condition identified.Correction: optia field action 24 has been initiated to correct this issue by releasing a safety notification to all optia users to express the importance of entering the correct patient data and following the operator's manual and on-screen prompts.Optia field action 24 will additionally address this issue by updating all optia devices in the field to software version 11.3.This software version will allow the optia device to determine if entered patient height and weight combinations are feasible.This upgrade was completed for this device on (b)(6) 2016 and will no longer allow height and weight data entry errors.Corrective action: an internal capa has been initiated to address incorrect patient data entry.The optia device at the customer's site was updated to the new software version 11.3.Investigation is in process.A follow up report will be provided.
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Event Description
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An internal investigation was performed of events in which an operator may have incorrectly entered patient data, creating an unreasonable body mass index (bmi).This event was identified during the internal investigation, not reported by the customer, therefore patient outcome is not available.Patient information is not available at this time.Entered weight of patient: (b)(6) entered height of patient: (b)(6) calculated (b)(6) protocol performed: white blood cells (wbc) collection.
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Event Description
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The customer declined to provide patient information or further procedural details for thisevent.
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Manufacturer Narrative
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This report is being filed to provide additional information in corrected infromation in e.4 and g.3.Root cause: user interface issue.
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Search Alerts/Recalls
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