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 Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Per the pst, the auxiliary printed circuit board assembly (pcba) was inspected and he found no damage or blown components that would have left damage on the sbc.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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The product surveillance technician (pst) reported that during routine testing of the device at the service center, the single board computer (sbc) had charred marking on p1 and u8 connectors.There was no patient involvement.
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Search Alerts/Recalls
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