Model Number 831F75 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Multiple attempts were made to secure return of the device however the customer has not responded nor sent the device back for evaluation.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.The lot number was not provided thus a device history record was not reviewed.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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Event Description
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It was reported there was inaccurate core values with swan ganz model 831f75.Customer stated their swan ganz had faulty temp probes and that this caused faulty readings and treatment.No allegations of patient injuries reported.
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Manufacturer Narrative
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Corrections and updates to the h6 codes are as follows health effect impact code was changed to inadequate inappropriate treatment or diagnostic exposure, investigation findings was changed to no findings available, and investigation conclusions was changed to cause not established.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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Search Alerts/Recalls
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