The hospital's biomed reported that on (b)(6) 2020 the patient was found on the floor unresponsive and pulseless.Cpr was applied, however, resuscitation of the patient was unsuccessful.The date and time of the patient's death was (b)(6) 2020 at 03:42 am.The nurse's advised that leads were showing as disconnected, but there wasn't any indication of it being disconnected in the room.
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Based on our investigation, the device had physical damage caused by use of unsupported cleaners.And/or cleaning methodologies, that impacted the device¿s ability to monitor the patient and generate physiological alarms reliably.The device generated inop alarms, for patient-cable connectivity issues appropriately.At the repair bench, the case, including the pins, were replaced.And the device was updated to the latest manufacturing process, with all tests passing per specifications.The device was returned to the hospital site to resume use.(b)(4), addresses pin corrosion and was issued to provide education on the proper cleaning techniques for mx40 telemetry devices.(b)(4), addresses mx40 and accessories.And was issued to provide education on the proper cleaning techniques for mx40 telemetry devices and their accessories.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
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