Model Number 14.1.1 |
Device Problems
Computer Software Problem (1112); Application Program Problem (2880); Unintended Application Program Shut Down (4032)
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Patient Problem
Death (1802)
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Event Date 01/22/2020 |
Event Type
Death
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Manufacturer Narrative
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The reporting facility stated that the device did not cause or contribute to the death of the patient.Initial investigation revealed the root cause of the reported malfunction is associated with the hardware components of the device.The hardware components were replaced, and then monitored by the reporting facility.The reporting facility confirmed the rt monitor is working as designed since the replacement.The hardware associated with the failure is under further investigation.Change healthcare will provide a follow up report to the agency once additional information is available.
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Event Description
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It was reported that during a procedure in the catheterization lab involving a patient in full cardiac arrest undergoing cpr, defibrillation, and artificial ventilation, that the rt monitor went blank multiple times and rebooted for several seconds and returned to full functionality.During the procedure and the reported rt monitor blanking out events, as indicated in the device instructions for use auxiliary devices were used to monitor the patient's vital signs.Subsequent to the procedure the patient expired.
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Manufacturer Narrative
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The reporting facility stated that the device did not cause or contribute to the death of the patient.Initial investigation revealed the root cause of the reported malfunction is associated with the hardware components of the device, as the hardware components were replaced, and no recurrence of this incident was reported by the reporting facility.Testing of pb-1000, one of the hardware components associated with the failure, concluded that it is within its specifications.The other hardware component (cu) was not received by change healthcare, despite a replacement unit that was sent to the customer.Multiple follow up attempts were made by phone and by email.Therefore, the cu component associated with the failure was not inspected.Due to the above, to date, change healthcare cannot determine the root cause of the failure.If additional information will be obtained, change healthcare will follow up with fda.
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Event Description
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It was reported that during a procedure in the catheterization lab involving a patient in full cardiac arrest undergoing cpr, defibrillation, and artificial ventilation, that the rt monitor went blank multiple times and rebooted for several seconds and returned to full functionality.During the procedure and the reported rt monitor blanking out events, as indicated in the device instructions for use auxiliary devices were used to monitor the patient's vital signs.Subsequent to the procedure the patient expired.
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Search Alerts/Recalls
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