The rse evaluated the device remotely.It was determined that the reinstallation of the software is required in order to restore functionality of the device.The software was ordered.The device remains at the customer site and no further evaluation is warranted at this time.Reporting address line 1: (b)(6), reporting address line 2: , reporter city: , reporting address state: , reporting address postal: , reporting institution phone: , reporter phone:.
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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 slow performance in the executing the commands.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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