Model Number KORA 250 DR |
Device Problem
Missing Test Results (3267)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/02/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The device model involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by sorin that was cleared or approved by fda for marketing in the united states.
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Event Description
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Reportedly, the p-wave and r-wave amplitude values were not displayed in the patient remote monitoring report.
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Event Description
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Reportedly, the p-wave and r-wave amplitude values were not displayed in the patient remote monitoring report.
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Manufacturer Narrative
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Preliminary analysis revealed that p-wave and r-wave amplitude values were not displayed due to a discrepancy between their recording time and the internal implant time.Normal behavior was observed in the following remote monitoring reports.
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Event Description
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Reportedly, the p-wave and r-wave amplitude values were not displayed in the patient remote monitoring report.
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Manufacturer Narrative
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Please refer to the attached analysis report.- attachment: [20200612 - file-2020-00714 - analysis_and_closure_report_resp-2020-00621.Pdf].
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Search Alerts/Recalls
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