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 malfunction although no additional patient information was communicated.Cardioquip's investigation could not confirm whether the device malfunctioned or if the device was put into standby mode unintentionally as the customer has not responded after multiple contact attempts.
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