Model Number DPTUNKNOWN |
Device Problem
Display or Visual Feedback Problem (1184)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2015 |
Event Type
malfunction
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Manufacturer Narrative
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The device evaluation is anticipated.However the complaint could not be confirmed without the completion of the product evaluation.A supplemental report will be forthcoming with the evaluation results.Lot number was not provided, therefore review of the manufacturing records could not be completed.
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Event Description
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As reported, in two dpts (disposable pressure transducer) the arterial blood pressure values provided were correct when the monitoring started in the operating room; however, the values suddenly increased when the patient was in the icu (intensive care unit).The alarm "high arterial pressure" was displayed on the monitor and the patient was treated according to the pressure values provided.Customer also verified all the connections of the device, and that the dpt was placed correctly.The patient was treated again in order to correct the therapy that was given based on inaccurate values.There was no allegation of patient injury.The sensor was changed for another one and the values displayed correctly.
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Manufacturer Narrative
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We received one triple dpt kit for examination.The iv tubing had be cut and part of the iv tubing with drip chamber was not returned.Priming solution was visible inside of the kit.All dpts zeroed and sensed pressure accurately on a pressure monitors.Pressure readings from all four dpts were stable during pressure drift test.Electrical testing also showed that the dpt electronic components were intact because both input and output impedances were within specifications.Zero-offset also met specification.No leakage or occlusion was detected from the kit during the pressure test.No visible defect was observed from the kit.The reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.No actions will be taken at this time.
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Manufacturer Narrative
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We received one single dpt with attached pressure tubing for examination.The dpt zeroed and sensed pressure accurately on a pressure monitor.The pressure reading from the dpt was stable during pressure drift test.Electrical testing also showed that the dpt electronic components were intact because both input and output impedance were within specifications.Zero-offset also met specification.No leakage or occlusion was detected from the kit during the pressure test.No visible defect was observed from the kit.The reported event was not confirmed.Although the cause of the complaint could not be determined, there was no indication of a manufacturing defect noted during the analysis.No actions will be taken at this time.
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Search Alerts/Recalls
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