EDWARDS LIFESCIENCES, PR TRUWAVE DISPOSABLE PRESSURE TRANSDUCER WITH STOPCOCK; TRANSDUCER, PRESSURE, CATHETER TIP
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Model Number PX600 |
Device Problem
Incorrect Measurement (1383)
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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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The device will not be returned for evaluation.Follow up attempts were made and the device is not available for return.Without the 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.A device history record review was unable to be completed as the lot number is unknown.Per a call with the customer, the clinical field specialist discovered it was due to use error and was not a device error.The customer was using the wrong type of transducer for their needs.The correct device was recommended for their monitoring requirements.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.H3 other text : device not available.
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Event Description
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It was reported that using this px600 pressure monitoring set, there were inaccurate readings.Troubleshooting was attempted several times, but the issue continued.The transducer was connected to a phillips monitor.There was no patient injury.
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Search Alerts/Recalls
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