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Model Number EV1000NI |
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 Known Impact Or Consequence To Patient (2692)
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Event Date 07/15/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product a supplemental report will be sent with the investigation results.Receiving and servicing documents from the device history record were reviewed; no related non-conformances were found.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 use with a patient of this ev1000 ni system, there was a difference of 100mmhg between the pressure value by the clearsight and the value given by the arm cuff.The clearsight value was 50 mmhg while the arm cuff value was 150 mmhg.The expected value was 130-150 mmhg.The patient was not treated based on the inaccurate values.There was no error message displayed.There was no allegation of patient injury.The platform was available for evaluation.
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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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