This report is based on information provided by philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the dfm100 device indicating that the therapy is deactivated.There was reportedly no patient involvement.Multiple attempts were made to request information regarding resolution of the reported problem.No response was received, so no information is available.This will be documented as a malfunction, the cause of which was not determined.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 never identified.The reported problem was not confirmed.A review of the risk management file indicates the problem reported by the customer was no reported patient death or serious injury, however the reported issue/event impacts or potentially impacts therapy, which could cause or contribute to a death or serious injury if the malfunction were to recur.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.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : customer did not respond to multiple requests for additional information.
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