FDA Adverse Event Summary report: N

STELLATE

MDR report key: 2502465 · Received March 21, 2012

Report

Report Number
2502465
Date Received
March 21, 2012
Date of Event
February 2, 2011
Report Date
March 21, 2012
Manufacturer
NATUS MEDICAL INCORPORATED
Product Code
GWQ
Report Source
User Facility report
Reporter Location
ME, US

Narratives

Description of Event or Problem · 1

PATIENT WAS UNDERGOING LONG TERM (SEVERAL DAYS) EEG MONITORING ON A PATIENT FLOOR. AT SOME POINT, THE PATIENT WAS LEAVING TO USE THE RESTROOM WITHIN THE PATIENT ROOM AND THE EEG DATA STOPPED BEING CAPTURED ALTHOUGH THE EQUIPMENT REMAINED IN THE RECORD MODE. THE NURSE PAGED THE EEG TECH AND HE UNPLUGGED AND RE-SEATED DIFFERENT CONNECTIONS. SOME MISCOMMUNICATION OCCURRED BETWEEN THE NURSE AND THE EEG TECH AND EACH FELT THE PROBLEM WAS RESOLVED BUT IN FACT IT WAS NOT. THE FOLLOWING MORNING THE NEUROLOGIST WAS ATTEMPTING TO REVIEW THE STUDY AND FOUND NO BRAIN ACTIVITY RECORDED. THIS TIME THE 'HEAD BOX' AND 'CONNECTIONS' WERE RE-SEATED AND THE MACHINE WAS RE-BOOTED AND THE EQUIPMENT OPERATED FINE. THE OEM TRAINED BIOMED INVESTIGATED AND IN HIS OPINION, DETERMINED THAT THE HEADBOX WAS DISCONNECTED UPON THE PATIENT'S TRIP TO THE BATH ROOM WHICH CAUSED A 'GLITCH' IN THE SOFTWARE THAT DID NOT RE-INITIALIZE SO THE PC CONTINUED TO RECORD ZERO SIGNAL. HIS ALTERNATE THEORY IS THAT THE HEAD BOX MAY NEVER HAVE BEEN PLUGGED BACK IN. THIS INCIDENT WAS NOT REPORTED TO CLINICAL ENGINEERING BECAUSE THE EEG AND NURSING STAFF FELT THE PROBLEM WAS SIMPLE AND WAS RESOLVED EASILY. I AM REPORTING THIS ALMOST A YEAR POST INCIDENT. I DON'T KNOW FOR SURE IF THIS WAS A SOFTWARE GLITCH OR HUMAN ERROR. WE COULD NOT REPRODUCE THE PROBLEM. THE EQUIPMENT HAS RUN FOR 12 MONTHS WITHOUT FURTHER INCIDENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 STELLATE SYSTEM, EEG MONITORING GWQ NATUS MEDICAL INCORPORATED HSYS-REC-EAMP *

Patients

Seq Age Sex Outcome Treatment
1 *