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 500AVHCT |
Device Problem
Smoking (1585)
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Patient Problem
No Patient Involvement (2645)
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Event Date 05/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The srt replaced the defective lcd backlight driver.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 damaged liquid crystal display (lcd) back light driver is causing smoke and a blank display while turning on 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 evidence of high surface temperature associated with electrical shorts on the transformer.Power was reaching the transformer and increasing the temperature when power is applied.The highest observed temperature coincides with the discolored region observed.Ac output was zero volts (v).The transformer on the inverter had failed.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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Manufacturer Narrative
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The reported complaint was confirmed.Per supplier evaluation, there was a black shrink wrap, about 2 and 3/4 inches, applied to the inverter, covering the inverter from the high voltage section back to the integrated circuits (ic).This was removed and it was noticed that the return wire was broken and burnt.The breakage of the wire was most likely from handling or flexing of the printed circuit board (pcb) during installation or when heat shrink was applied.The burning was from operation of the inverter after the wire breakage.It was determined that the broken return wire was the reason of the inverter failure.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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