FDA Adverse Event Malfunction Summary report: N

OBIX

MDR report key: 2451163 · Received January 30, 2012

Report

Report Number
2451163
Event Type
Malfunction
Date Received
January 30, 2012
Date of Event
June 19, 2011
Report Date
January 6, 2012
Manufacturer
CLINICAL COMPUTER SYSTEMS, INC.
Product Code
HGM
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

FROM INCIDENT REPORT: APPROXIMATELY 6 MONTHS AGO DURING THE EVENING SHIFT THE AUDIO ALARM FOR THE FETAL MONITORING SYSTEM (OBIX) AT THE L&D NURSES STATION WAS REPORTED TO BE NOT SOUNDING. I ASKED CALLER TO MAKE SURE THAT THE VOLUME WASN'T MUTED OR TURNED ALL THE WAY DOWN ON THE DESKTOP. SHE SAID THAT SHE HAD ALREADY CHECKED IT AND THE VOLUME WAS TURNED ALL THE WAY UP. I CAME IN TO FIND THAT THE AUDIO CABLE FOR THE OBIX ALARM HAD BEEN DISCONNECTED FROM THE DISPLAY. SINCE THE SPEAKERS ARE BUILT INTO THE DISPLAY THE AUDIO ALARM WOULD NOT HAVE SOUNDED WITH THE CABLE DISCONNECTED. I PLUGGED THE AUDIO CABLE BACK INTO THE DISPLAY AND CONFIRMED THAT THE AUDIO ALARM IS NOW SOUNDING. THIS IS THE 3RD TIME THAT THIS CABLE WAS FOUND DISCONNECTED. THE DISPLAY THAT THE AUDIO CABLE PLUGS INTO IS STATIONARY AND THE AUDIO CABLE ITSELF IS PLUGGED IN AT THE REAR OF THE DISPLAY MAKING IT VIRTUALLY IMPOSSIBLE TO HAVE BEEN ACCIDENTALLY UNPLUGGED. I SUSPECT THAT USERS ARE DISCONNECTING THE CABLE TO SILENCE THE AUDIO ALARM. THIS IS A CLASSIC CASE OF ALARM FATIGUE WHERE THE ALARMS ARE SO FREQUENT AND DISRUPTIVE THAT USERS INTENTIONALLY DEFEAT THE ALARM AUDIO. THE ALARM PARAMETERS NEED TO BE MORE CONFIGURABLE TO MINIMIZE THE NUISANCE ALARMS. ESPECIALLY BOTHERSOME IS AN ALARM FOR ECG SIGNAL DROPOUT, WHICH HAPPPENS FREQUENTLY WITH TWINS. THE PREVIOUS SYSTEM HAD A DELAY WHICH WOULD NOT ALARM UNLESS THE SIGNAL DROPPED OUT FOR LONGER THAN A PRESET TIME. OBIX ALARMS INSTANTLY WHEN ECG SIGNAL DROPS OUT.======================MANUFACTURER RESPONSE FOR PERINATAL DATA SYSTEM, OBIX (PER SITE REPORTER).======================SOME ISSUES SHOULD BE RESOLVED WITH NEXT VERSION OF SOFTWARE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 OBIX PERINATAL DATA SYSTEM HGM CLINICAL COMPUTER SYSTEMS, INC. OBIX *

Patients

Seq Age Sex Outcome Treatment
1 *