This report is based on information provided by philips field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl+ indicating that the ecg cable has issues.The fse evaluated the device on site.It was determined that this was a malfunction of the ecg cable 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 ecg cable.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 ecg cable to resolve the issue.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.
|