It was reported there was device leakage.Additional details have been requested.There was no patient involvement.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model# 861290) and will be reported in the united states under device model# 861290.
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Philips received a complaint on the dfm100 device indicating leakage.There was reportedly no patient involvement.The fse evaluated the device on site.It was determined that this was a malfunction of the nibp (non-invasive blood pressure) cuff, which was replaced, and the device was returned to full functionality.The device remains at the customer site and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the nibp (non-invasive blood pressure) cuff.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The fse replaced the nibp (non-invasive blood pressure) cuff to resolve the issue.It has been concluded that no further action is required at this time.
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