It was reported to philips that the device's software is corrupted.There was no patient involvement.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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The rse provided remote support and arranged for the asp to perform service on site.The asp evaluated the device on site and determined that there was a malfunction of the som pca.The som pca was replaced, and the device was returned to full functionality.The device¿s hardware and software logs were requested, but they are not available.The device remains at the customer site and no further evaluation is warranted at this time.
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