FDA Adverse Event Malfunction Summary report: N

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MDR report key: 999149 · Received January 9, 2008

Report

Report Number
999149
Event Type
Malfunction
Date Received
January 9, 2008
Date of Event
December 10, 2007
Report Date
January 8, 2008
Manufacturer
NICOLET BIOMEDICAL
Product Code
GWQ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
WI, US

Narratives

Description of Event or Problem · 1

THE NICOLETONE NEEG AMPLIFIER HAS AN EVENT BUTTON FOR THE NURSES OR FAMILY TO PRESS WHEN THE PATIENT IS SEIZING. ACTIVATION OF THE EVENT BUTTON WILL MARK THE PATIENT'S RECORD AND ACTIVATE A RELAY. THE RELAY IS USED TO CALL THE NURSE FOR HELP BY ACTIVATING THE NURSE CALL SYSTEM. THE MARKING OF THE RECORD WORKS FINE WITH EVERY BUTTON PRESS. THE NURSE CALL ACTIVATION WILL NOT WORK IF THE BUTTON IS PRESSED MORE THAN ONCE IN A TWO SECOND PERIOD. THE BUTTON CAN BE REPEATEDLY PRESSED FOR LONG PERIODS OF TIME WITHOUT TRIGGERING A CALL TO THE NURSE. IF THE BUTTON IS PRESSED JUST ONCE IT WORKS FINE. THERE IS A TWO SECOND DELAY FROM WHEN THE BUTTON IS PRESSED TO WHEN THE NURSE CALL IS ACTIVATED BY THE NICOLET RELAY. THIS DELAY MAY CAUSE THE USER TO PRESS THE BUTTON AGAIN BECAUSE IT APPEARS AS THOUGH IT DIDN'T WORK THE FIRST TIME.====================== MANUFACTURER RESPONSE FOR LONG-TERM EEG MONITOR, NICOLET BIOMEDICAL======================THEY HAVE REPRODUCED THE PROBLEM. THEY MAY TRY TO RESOLVE THROUGH CHANGES IN THE SOFTWARE PROGRAMMING.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * MONITOR, EEG GWQ NICOLET BIOMEDICAL NEEG *

Patients

Seq Age Sex Outcome Treatment
1 *