Catalog Number 8065750833 |
Device Problem
Computer Operating System Problem (2898)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A nurse reported that the system locked completely when the system was turned on.No patient harm was reported.Additional information is requested.
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Manufacturer Narrative
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The previous report submitted for this event contained an error in h.1.- ¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The system was examined and the reported event was confirmed.The company representative resolved the issue by reseating the cabling.The system was tested and found to meet product specifications.The manufacturing device history record (dhr) was reviewed.Based on qa assessment, the product met specifications at the time of release.The root cause of the reported event can be attributed to a cable contact needing to be reseated.However, how or when the cable became non-conforming remain inconclusive.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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