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 05/23/2014 |
Event Type
malfunction
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Manufacturer Narrative
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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) kg.Entered height of patient: 88 cm.Calculated bmi: 232.4.Protocol performed: therapeutic plasma exchange (tpe).
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Manufacturer Narrative
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This report is being filed to provide in 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 two additional issues related to thereported condition identified.These were reported in 1722028-2019-00206 (aug.2019) and1722028-2019-00205 (aug.2019) respectively.Correction: optia field action 24 has been initiated to correct this issue by releasing a safetynotification to all optia users to express the importance of entering the correct patient data andfollowing 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 tosoftware version 11.3.This software version will allow the optia device to determine if enteredpatient height and weight combinations are feasible.This upgrade was completed for this deviceon october 14, 2016 and will no longer allow for height and weight data entry errors.Corrective action: an internal capa has been initiated to address incorrect patient dataentry.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide in root cause: user interface issue.
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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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Search Alerts/Recalls
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