XLTEK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-10-08 for XLTEK * manufactured by Natus Medical Incorportated.

Event Text Entries

[4784267] Patients are admitted for continuous video electroencephalography (eeg) monitoring to specific fully monitored beds within an epilepsy monitoring unit (emu). The monitoring system includes two monitors located at the nurse's station. At the nurse station monitors, the nurses can adjust a camera that is mounted within the patient's room, as well as suspend the audio alarm that gets activated when the patient is having a seizure. The eeg technician noticed that the alarms were not going off when she tested (by pressing) the event button attached to the monitoring equipment. That button registers in the system an electronic log when the patient presses a button on the acquisition unit in the patient's room. This time, it did not set off the audible alarm at the nurse's station. After much troubleshooting from the technician and the equipment vendor, the following source of the problem was identified. It is suspected that someone accessed the system and manually changed the settings within the settings section of the computer at the nurse station monitor. This act changed the established settings. We identified two potential problems. The alarm severity setting had been changed from high to low. This resulted in a lower audible sound coming out of the nurse station monitor. The other setting that was changed related to the patient's event button. When a patient feels a seizure coming on, they are instructed to press the event button to log the event on the system, but it will also set off an audible alarm at the nurse's station. What was discovered is that all of the settings associated with this button being activated were shut off. When the eeg technician asked the technical support technician from the vendor company if there was any other way that these settings could become deactivated, beyond human manipulation, he said no. He said that someone would have had to have gone into the settings and have changed them, but this could not be replicated. The technical support person returned the settings to the correct default values, and the problem was considered resolved. However, nursing has also put every four hour alarm checks in place during the evenings and nights. The system has worked as intended, but there remains concern that the problem lies within the computer and is not a problem of someone inadvertently having changed a setting - so this is being submitted to alert the company that there could be a problem within the system itself that caused these two changes, which are safety concerns.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4160685
MDR Report Key4160685
Date Received2014-10-08
Date of Report2014-10-08
Date of Event2014-08-10
Report Date2014-10-08
Date Added to Maude2014-10-10
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameXLTEK
Generic NameXLTEK/NATUS EPILEPSY MONITORING UNIT NURSE STATION ALARM SYS
Product CodeOMB
Date Received2014-10-08
Returned To Mfg2014-09-12
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityR
Device Sequence No1
Device Event Key0
ManufacturerNATUS MEDICAL INCORPORTATED
Manufacturer Address1501 INDUSTRIAL ROAD SAN CARLOS CA 94070 US 94070

Device Sequence Number: 2

Brand NameXLTEK
Generic NameXLTEK/NATUS EPILEPSY MONITORING UNIT NURSE STATION ALARM SYS
Product CodeOMB
Date Received2014-10-08
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityR
Device Sequence No2
Device Event Key0
ManufacturerNATUS MEDICAL INCORPORTATED
Manufacturer Address1501 INDUSTRIAL ROAD SAN CARLOS CA 94070 US 94070


Patients

Patient NumberTreatmentOutcomeDate
10 2014-10-08

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