FDA Adverse Event Malfunction Summary report: N

INTELLIVUE

MDR report key: 1709197 · Received May 21, 2010

Report

Report Number
1709197
Event Type
Malfunction
Date Received
May 21, 2010
Date of Event
May 1, 2009
Report Date
May 21, 2010
Manufacturer
PHILIPS MEDICAL SYSTEMS
Product Code
MHX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
AZ, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

EQUIPMENT INSTALLATION (B)(6) 2009 WAS PHASED TO "GO LIVE" DURING (B)(6). (B)(6) THE HOSPITAL EXPERIENCED A NUMBER OF ISSUES. MULTIPLE INSTANCES OF DATABASE SERVER (DBS) REBOOTING CAUSING THE PATIENT INFORMATION CENTER (PICS) TO GO INTO LOCAL MODE AND FOR THE CLIENTS TO GO OFF LINE. MOUSE FAILURES WITH THE REMOTE CPU SOLUTION AND KEY BOARD, MONITOR, VIDEO (KVM) SWITCHES. THE PIC REBOOTS OR GOES BLANK RANDOMLY; PIC RECOVERS, HOWEVER DATA IS LOST DURING THE TIME OF THE "BLANKING" OR REBOOTING. PRINTERS ARE GOING OFF LINE AND UNABLE TO PRINT. SYSTEM TESTED FOR HARDWARE FAILURES AND OR OBVIOUS CONFIGURATION ISSUES. SOME HARDWARE DEVICES KVM SWITCH AND MOUSE WERE REPLACED. THE RESULT OF THE PROCESS WAS THE PHILIPS LOCAL SERVICE ENGINEER WAS UNABLE TO ISOLATE ANY OBVIOUS SOURCE OF FAILURE. THERE WAS A FORMAL ESCALATION IN (B)(4) TO THE PHILIPS REGION SUPPORT MANAGER. ALL LOGS FROM SERVERS WERE SENT TO PHILIPS MONITORING HQ FOR ANALYSIS. DBS REBOOTS ERROR LOGS INDICATE THAT THE SYSTEM WAS THOUGHT THAT IT HAD RUN OUT OF AVAILABLE MEMORY AND CREATED A REBOOT TO DUMP ITS MEMORY CONTENT. PHILIPS ANALYZED THE SOFTWARE CODE AND DISCOVERED AN ERROR IN THE CODE THAT CREATED AN ERRONEOUS MEMORY CAP. A PATCH WAS CREATED IN (B)(4) WHICH CORRECTED THE PROBLEM. PRINTERS GOING OFF LINE WERE HOSPITAL PROCURED PRINTERS WHICH POSSESS 2 NIC CARDS INSTEAD OF ONE. THIS PROBLEM WAS MOST PREVALENT ON THE LEAST ACTIVE PRINTERS AND PHILIPS PROVIDED 2 DIVISION PRINTERS FOR THESE AREAS WHICH WERE INSTALLED IN (B)(4) WITH NO FURTHER ISSUES. PIC REBOOTS ANALYSIS OF THE ERROR LOGS INDICATED 2 TYPES OF ERROR GENERATED BY THE PICS WHEN THEY WOULD HAVE A DOCUMENTED A REBOOT OCCURRENCE LOSS OF COMMUNICATION WITH THE DBS AND NETWORK MESSAGING A "DR WATSON" ERROR (A SOFTWARE ERROR THAT MAY OCCUR WHEN COPYING OR PASTING FILES USING WINDOWS EXPLORER). IN (B)(4) THE MEMORY LEAK PATCH WAS PERFORMED WHICH ELIMINATED THE REBOOTS ASSOCIATED WITH THE DBS REBOOT. REBOOTS GENERATING THE OTHER ERROR CONTINUE. REMOTE SERVER NETWORK (RSN) CONNECTION ESTABLISHED TO FACILITATE DOWNLOADS OF ERROR LOGS AND DEPLOYMENT OF REPORTING TOOLS THAT CAPTURE AND DRILL DOWN. MOUSE LOCK UPS IN THE REMOTE SOLUTION LED TO INVESTIGATION OF THE TECHNOLOGY USED TO COMMUNICATE BETWEEN THE REMOTE CPU AND KVM SWITCH. THE INITIAL TECHNOLOGY INSTALLED EXTENDED THE PS/2 MOUSE COMMUNICATION PROTOCOLS BETWEEN THE CPU AND MOUSE. THE LOCKUPS TEND TO OCCUR RANDOMLY AND HAVE HAPPENED IN ALL FOUR WORKSTATIONS, HOWEVER, MOST PREVALENT IN THE STATIONS ALONG THE WINDOW. REMEDY WAS TO CONVERT THE REMOTE SOLUTION FROM A PS/2 TO A USB, REPLACE HARDWARE COMPONENTS WITH ANOTHER STYLE, AND UPGRADE TO "KAVOOM" KVM SWITCH SOFTWARE. THIS SEEMS TO BE WORKING AS THE MONITOR TECH CAN SCROLL THROUGH THE FOUR MONITORS WITHOUT LOCKING UP, HOWEVER, LIMITS THE MONITORING CAPABILITY OF EACH MONITOR TO 12 PATIENTS INSTEAD OF THE 16 PATIENTS THAT ARE ADVERTISED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 INTELLIVUE CLINICAL TELEMETRY MONITOR NETWORK MHX PHILIPS MEDICAL SYSTEMS M3185A *

Patients

Seq Age Sex Outcome Treatment
1 *