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
Thermal Decomposition of Device (1071)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/08/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The reported complaint was confirmed.During laboratory analysis, the product surveillance technician (pst) observed the monitor to have no viewable liquid crystal display (lcd) display back ground.The lcd invertor printed circuit board assembly (pcba) revealed a hi voltage coil was opened or shorted, producing heat which melted the surrounding cover on the pcba.The pcba no longer produces the required alternating current (a/c) voltage to drive or operate the lcd display properly.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, the display on the unit was dark.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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