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Model Number EVHRS |
Device Problems
Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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Event Date 09/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The product is expected to be returned for further analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.The device history record was reviewed; no related non-conformances were found.There is no escalation is required.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.
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Event Description
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As reported during evaluation, when the set point was at -40cm for the hrs pressure test, the measured value was 41mmhg.The specification range should be between 29 - 33mmhg.There was no patient involvement.
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Manufacturer Narrative
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The evhrs was returned for evaluation.The reported issue was not confirmed by the evaluation.When the hrs was connected to a known working system, the initial value was +9mmhg when the ends were aligned.It was possible to zero the hrs with no issue.The evhrs was ran on the functional tester and passed all tests.With any hemodynamic monitoring, pressure readings can change quickly and dramatically.Cardiac output readings should correlate with the patient¿s clinical manifestations.These devices are used by highly trained clinicians experienced in assessing and mitigating any hazards that arise.These devices are typically used in intensive care units or operating rooms where patients are closely monitored.It is unknown whether any user or procedural factors contributed to this reported 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 a part of the monthly review.
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Manufacturer Narrative
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Corrected data: f10, h6.Reference capa-20-00141.
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Search Alerts/Recalls
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