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 Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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The service repair technician (srt) reported that during testing of the device at the service center, the blood parameter monitor (bpm) had a heat damaged capacitor at the c135 position on the auxiliary (aux) printed circuit board assembly (pcba).There was no patient involvement.
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Manufacturer Narrative
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The reported complaint was confirmed.The srt replaced the aux pcba.The unit operated 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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Search Alerts/Recalls
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