CINCINNATI SUB-ZERO PRODUCTS, LLC/GENTHERM MEDICAL, LLC HEMOTHERM; CONTROLLER, TEMPERATURE, CARDIOPULMONARY BYPASS
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Device Problem
Failure of Device to Self-Test (2937)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/15/2022 |
Event Type
malfunction
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Event Description
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When heater/cooler was turned on for checks in the morning it triggered a circuit alarm.Unit was turned off and another attempt was made.Alarm resumed.Unit was exchanged with another, pulled for service, and biomed notified.This all occurred prior to patient being in the operating room.Fda safety report # (b)(4).
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Search Alerts/Recalls
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