Philips field service engineers (fse) visited the customer site and extracted the alarm audit logs and additional data.The corresponding excerpt from the piic ix alarm audit logs for h6839 is shown as consistent alarms were captured on the piicix from 10:53 until the patient was discharged at 11:53, after which no significant activity other than settings/configurations occurred.Although the short range radio disconnection between the mp5 and the mx40 occurred, philips has confirmed that no product malfunction has occurred.The customer has reported that the mp5sc showed a ¿tele disconnect¿ inop during the event and that the waveforms continued on the mx40 all while continuously transmitting data, including alarms, to the piicix.A review of the piicix alarm audit log also showed consistent alarming from 10:53 until 11:53, when the patient was discharged.The customer has confirmed operational functionality, including short range radio, of both the mp5sc and the mx40 and has continued clinical use of the devices on patients.Philips provided the customer with recommendations concerning the radio frequency codes of nearby rooms as well.The customer also resolved a site-wide network issue of quantum data loss by a software patch, which is described in further detail in (b)(4).Good faith efforts to obtain additional patient information was conducted, but the customer was not willing to provide this information.No corrective action is required at this time.The device did not cause a death or serious injury, and the available information from this complaint and its associated records does not support that this failure represents a systemic, design, or labeling problem.No further investigation is required.
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