Philips received a complaint on the efficia dfm100 defibrillator indicating that there was an ecg fault.Available details indicate that the device gave an ecg fault.Details provided in an update from the source case indicate that the user was instructed to perform the operation check without ecg leadwire connection, which confirmed the device function checked normal.No fault was found and the device was returned into service.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.A review of the risk management file was performed, and the potential severity of s3 has been identified in the risk document.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 device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.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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