This report is based on information provided by philips remote service personnel and has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 defibrillator/monitor indicating that the device had error 9:13.Available details indicate that the device had exhibited symptoms of a failure.The engineer provided support and found the processor pca assembly must be replaced.The device is not available for investigation due to a logistical limitation that is preventing the return of the device.When the limitation has been resolved and the device is returned to philips, the complaint shall be reopened to document further investigation.Based on the information available and the testing conducted, the cause of the reported problem was the processor pca assembly.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 device was operational after repairs were completed.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.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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