Model Number 860343 |
Device Problem
Patient Data Problem (3197)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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A follow-up report will be submitted once the investigation is complete.
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Event Description
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Customer reported the patient information saved to the wrong patient when they saved it after an exam.There was no patient harm or injury reported.
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Manufacturer Narrative
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H10: during review of this pr for the opened rce/ca, it was discovered this issue occurred for the customer with 6 different patients on the same day.In light that the rce/ca has determined this issue is a severity level 2 (severity levels s2 and s1 are not serious adverse health consequences per hhe form) and no adjustments need to be made to the sra as the sra has already accounted for this risk, this record will not be split for each individual event.If this event were to recur, this will not result in a serious injury.In conjunction with the issue reported in this incident, there was no adverse event reported.This issue has now been deemed non-reportable.All events will remain on the current record.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Manufacturer Narrative
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H10: customer contacted the customer care solutions center(ccsc) to report the issue.Ccsc requested assistance from the product support engineer(pse).Customer stated this occurred only once and has not occurred again since this incident.Research and development is currently investigating this issue.The issue could not be confirmed.A workaround was provided to the customer while the issue is investigated, root cause found, and a solution provided.Workaround: instead of clicking "ok" when adding a new patient in the patient id screen, click the "save" button to save patient to worklist, then select this patient from the worklist.It was determined that both a regulatory compliance evaluation and a clinical assessment (rce/ca) is required due to the nature and frequency of this complaint.Issue is software related, but still in progress.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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Search Alerts/Recalls
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