FDA Adverse Event Malfunction Summary report: N

EARLYSENSE

MDR report key: 6165345 · Received December 11, 2016

Report

Report Number
3008693420-2016-00001
Event Type
Malfunction
Date Received
December 11, 2016
Date of Event
September 29, 2016
Report Date
October 27, 2016
Manufacturer
EARLYSENSE LTD
Product Code
OUG
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
IS
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

ON SEPTEMBER 29, 2016 THE (B)(6) REPORTED THE FOLLOWING: THE EARLYSENSE 2.0 MONITORING DEVICE (BEDSIDE) UNIT PROVIDED A BED EXIT ALERT TO THE HEALTHCARE PRACTITIONERS INDICATING PATIENT EXITING THE BED. THE EARLYSENSE CENTRAL DISPLAY STATION (CDS), ALSO PROVIDED THE BED EXIT ALERT AT THE SAME TIME AT THE NURSING STATION. THE BED EXIT ALERT IN THE BEDSIDE UNIT WAS SET TO A LOW LEVEL SENSITIVITY. THE TECHNICAL LOG FILES SHOWED THAT THE ALERT WAS CONFIRMED BY (B)(6) STAFF AT THE BEDSIDE. THE ALERT TO THE EXTERNAL MOBILE ALERTING DEVICE (CISCO PHONES) WAS NOT TRANSFERRED DURING THIS EVENT, DUE TO GATEWAY COMPUTER CONNECTIVITY ISSUE. AT THAT TIME, THE PATIENT EXITED HIS BED, FELL AND FRACTURED A BONE. THE PATIENT WAS NOT TRANSFERRED TO A HOSPITAL OR EMERGENCY ROOM AND HE IS RECOVERING WELL. IN CONCLUSION: THE EARLYSENSE BEDSIDE UNIT AND CENTRAL DISPLAY STATION WERE PERFORMING AS EXPECTED ACCORDING TO THEIR SPECIFICATIONS. HOWEVER, THE GATEWAY WAS NOT SUPPORTING THE DELIVERY OF THE EARLYSENSE ALERTS TO THE EXTERNAL MOBILE ALERTING DEVICES THAT BELONG TO THE HOSPITAL ( CISCO PHONES). THIS MAY HAVE POTENTIALLY CONTRIBUTED TO THE REPORTED INCIDENT. CORRECTION PROVIDED TO THE SITE. UPDATED GATEWAY SOFTWARE WAS INSTALLED IN COLLABORATION WITH THE HOSPITAL IT THAT RECOGNIZES WHEN THE GATEWAY APPLICATION IS "DOWN' (WATCHDOG) AND RESTARTS THE GATEWAY SO THE EXTERNAL ALERTING DEVICES ARE SUPPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
816196 EARLYSENSE MEDICAL DEVICE DATA SYSTEM - GATEWAY OUG EARLYSENSE LTD GATEWAY SOFTWARE

Patients

Seq Age Sex Outcome Treatment
1