Catalog Number 0998-00-3013-XX |
Device Problems
Incorrect Or Inadequate Test Results (2456); Low Readings (2460); Device Operates Differently Than Expected (2913)
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Patient Problem
Death (1802)
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Event Date 01/17/2017 |
Event Type
Death
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Manufacturer Narrative
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The production device history record (dhr) for the iabp involved in the event was reviewed.There were no non-conformances in the dhr related to the reported event.
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Event Description
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Customer reported that the systolic and diastolic blood pressure shown in the iabp monitor is less compared to the bed side monitor.Further, it was reported the bp was measured (via the radial artery) and monitored on the bedside monitor the customer is alleging the iabp malfunctioned and is attributing the malfunction to the patient's death.
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Manufacturer Narrative
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Additional information: furthermore, the company representative explained the reason for the difference in pressures between the iabp (intra-aortic balloon pump) monitor and the bedside monitor.The information conveyed that the iabp was working well.Additional tests were also conducted to check the consistency of pressure displayed in the iabp system and they were found to be correct.The company representative conducted an in service program to the hospital departments as a proactive measure.During follow up communication between the company representative and the customer, the customer reported that the patients' death was not attributed to the device.Furthermore, the company representative explained that the reason for the difference in pressures between the iabp (intra-aortic balloon pump) and the bedside monitor conveyed that the iabp was working well.
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Event Description
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Customer reported that the systolic and diastolic blood pressure shown in the iabp monitor is less compared to the bed side monitor.Further, it was reported the bp was measured (via the radial artery) and monitored on the bedside monitor the customer is alleging the iabp malfunctioned and is attributing the malfunction to the patient's death.
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Event Description
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Customer reported that the systolic and diastolic blood pressure shown in the iabp monitor is less compared to the bed side monitor.Further, it was reported the bp was measured (via the radial artery) and monitored on the bedside monitor the customer is alleging the iabp malfunctioned and is attributing the malfunction to the patient's death.
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Search Alerts/Recalls
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