TERUMO CARDIOVASCULAR SYSTEMS CORP. CDI BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
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Model Number 500AVHCT |
Device Problem
Failure to Power Up (1476)
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Patient Problem
No Patient Involvement (2645)
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Event Date 01/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The complaint is confirmed.Product evaluation found that the c28 capacitor on the auxiliary pcba board overloaded and burned.This prevented the board from relaying the supplied voltage to power the unit.During the laboratory evaluation, the reported issue was verified.The bpm unit did not operate with alternating current (a/c) power applied.The power supply cable was found to be defective.The product will be sent to service to be brought to manufacturers 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 the use of the device for a non-clinical activity (routine testing), the blood parameter monitor (bpm) was not turning on.There was no patient involvement.
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Search Alerts/Recalls
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