Model Number EVHRS |
Device Problems
Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/16/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for analysis; however, it has not yet been received.Upon return of the product a supplemental report will be submitted with the investigation results.
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Event Description
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It was reported that the heart reference sensor (hrs) device did not adjust for height changes.When the hrs was raised above the level of the finger side of the device, the values did not appropriately decrease from zero to a negative number.When the hrs was lowered below the level of the finger side of the device, the values did not appropriately increase to a positive number.There were no error messages observed.The hrs device was being tested.There was no patient involvement.
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Manufacturer Narrative
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One heart reference sensor (hrs) was received for product evaluation.The heart reference sensor was connected to a known good working clearsight system for testing.The hrs unit did not produce any error messages when tested.It was able to perform zeroing three times without any issues.A normal waveform and normal blood pressure readings were able to be displayed three times without any issues noted.The returned hrs unit was moved around, thus moving the internal flat flex cable and there were no error messages received.A visual inspection was performed and there was no physical damage found.There was no defect found.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported event was not confirmed by evaluation.There are no indications that this is related to the manufacturing process.It could not be determined if any procedural factors may have contributed to the event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No further actions will be taken at this time.
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Search Alerts/Recalls
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