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 Problems
Thermal Decomposition of Device (1071); Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/05/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The srt replaced the auxiliary (aux) board.The unit operated to the manufacturer's specifications.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 service repair technician (srt) reported that during routine testing of the device at the service center, the unit shut off during the boot-up process and then there was a burning smell coming from the unit.There was no patient involvement.
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Manufacturer Narrative
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During laboratory analysis, the product surveillance technician (pst) observed no burnt components on top or reverse side of printed circuit board assembly (pcba).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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Search Alerts/Recalls
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