TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS-CDI BPM SYSTEM 500
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Model Number 500AHCT |
Device Problem
Electrical /Electronic Property Problem (1198)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed that the monitor had no display when powered on.He inspected the inverter driver pcb and found a failed, burnt transformer.The product will be sent to service to be brought to manufacturer¿s specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
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Event Description
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It was reported that during set-up of the device for a cardiopulmonary bypass (cpb) procedure, nothing was displayed when the device was powered on.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
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