Model Number 896083L1B |
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 11/04/2019 |
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 as well as the device history record.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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It was reported that this truwave cable was giving intermittent low pressure readings.The cable was working initially, but after 20 minutes it began to give incorrect systolic readings.The disposable pressure transducer and the cable were replaced and then the measurements were as expected.The sales representative was unable to obtain the lot number or any further information regarding this issue.There is no allegation of patient injury reported.Patient demographics unable to be obtained at this time.The cable was available for evaluation.
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Manufacturer Narrative
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Through investigation it was found that this event does not meet the criteria for a complaint.It was communicated by the customer that the event was not caused by the truwave cable or another edwards device, therefore, there is no evidence or allegation that the use,misuse or malfunction of an edwards device caused or contributed to the event.Further information could not be obtained from the customer.The product will not be returned 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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