Model Number MCH-1000(M) |
Device Problem
Overheating of Device (1437)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/21/2021 |
Event Type
malfunction
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Event Description
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The device ran normally at 37 c , but when operated at 42c it went over the set point to 43.3 c after a few hours.The hoses were checked for kinks or clogs but none were found.It was noticed the motor impellar/pump was louder than usual.
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Manufacturer Narrative
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This device has not been received by cardioquip.Once the device has been received and the investigation has been completed, cardioquip will file supplementary reports.
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Manufacturer Narrative
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The manufacturer is reporting the following complaint after a voluntary review of all complaints (reportable or not) since 2016.This report is being filed now, after being scrutinized under a newly revised risk matrix, recently adopted after inspection.The customer notified cardioquip that a patient was involved during the event although no patient information was communicated.Cardioquip could not reproduce the issues reported by the customer during investigation.It was determined that the device was not operated with cold water in the water tank for an extended period leading to an overtemp error.The device was inspected and is fully operational.
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Event Description
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The device ran normally at 37 c, but when operated at 42c it went over the set point to 43.3 c after a few hours.The hoses were checked for kinks or clogs but none were found.It was noticed the motor impellar/pump was louder than usual.
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Search Alerts/Recalls
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