Model Number PC2K |
Device Problem
Incorrect Measurement (1383)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/20/2016 |
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 return of the product a supplemental report will be submitted with the investigation results.The device service history record review was completed and documented that the device met all specifications upon distribution.
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Event Description
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It was reported that while monitoring a patient during a neck surgery, there was a blood pressure reading discrepancy.There was a difference of 20 ¿ 30mmhg between the clearsight system and the nibp (non-invasive blood pressure).The patient also had an arterial line with a flotrac which correlated with the nibp.When the discrepancy was observed with the clearsight system, the clinician discontinued use of the system.There was no patient harm or injury.
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Manufacturer Narrative
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One pressure controller was received for product evaluation.The examination found that when the pressure controller was connected to a good working clearsight system, that there were no errors observed.The blood pressure readings that were displayed were normal readings.The fct1 and fct2 calibration tests were performed and the product passed both tests.There were no issues noted.The device service history record review was completed and all manufacturing inspections passed with no non-conformances.The reported issue was not confirmed by evaluation.There was no defect found.There are no indications that this is related to the manufacturing process.It could not be determined if any clinical or procedural factors may have contributed to the event.No further actions will be taken at this time.
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Search Alerts/Recalls
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