FDA Adverse Event Malfunction Summary report: N

CLINICOMP CIS AND FMRD SYSTEM

MDR report key: 173339 · Received June 4, 1998

Report

Report Number
MW4002273
Event Type
Malfunction
Date Received
June 4, 1998
Report Date
May 13, 1998
Manufacturer
CLINICOMP INTL.
Product Code
HEL
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

SUBJECTS: FETAL MONITOR REMOTE DISPLAY (FMRD) SCREEN FREEZING. 1. IN MAR 1998 FACILITY NOTICED THAT PC SCREENS STARTED TO FREEZE. THESE WERE ISOLATED INCIDENTS AND THE ONLY WAY TO UNLOCK THE SCREEN WAS TO REBOOT. REPORTED EACH TIME TO CLINICOMP. IT WAS FELT THAT IT WAS A PROBLEM WITH THE EMULATION. 2. SHORTLY AFTER THAT, THE "NCD" SCREENS BEGAN TO LOCK UP. AGAIN ISOLATED INCIDENTS, FACILITY WOULD CALL CLINCOMP, WHO COULD NOT SEE AN ERROR AND THEY STATED THEY HAD REPORTED IT TO SOFTWARE. THE INCIDENTS HAVE INCREASED SOMETIMES BEING AS MUCH AS 4-5 TIMES A WEEK. THE ONLY WAY TO RESOLVE WAS TO REBOOT. THIS HAPPENED IN NOTES APPLICATION AS WELL AS THE PT SELECT SCREEN, SEVERAL TIMES WHEN ATTEMPTING TO STORE. IT HAS HAPPENED ON PC'S AND "NCD'S" IN ALL LOCATIONS OF THE HOSP. 3. ON 1 MAY 1998 FACILITY HAD AN EPISODE WHERE THE FETAL MONITOR REMOTE DISPLAY SCREEN LOCKED IN A PT RM. CLINICOMP WAS UNABLE TO "PING" THE MONITOR. FACILITY CHECKED THE CONNECTIONS AND THE NETWORK. ONCE FACILITY REBOOTED, IT WORKED AGAIN. 7 MAY 1998 FACILITY HAD ANOTHER INCIDENT OF FETAL MONITOR REMOTE DISPLAY LOCKING UP. THIS PRESENTS A PROBLEM IF A PT IS BEING MONITORED IN THAT RM. 4. CLINICOMP HAS BEEN UNABLE TO LOCATE A SOFTWARE APPLICATION ABNORMALITY. "FMRG'S" ARE FDA DEVICES WHICH ARE NECESSARY TO MONITOR A PT IN LABOR."MY CONCERN IS IF THE SCREEN FREEZES WHILE CARING FOR AN ACTIVE LABOR PT, POTENTIALLY HARMFUL INFO COULD BE MISSED, AND A DETRIMENTAL OUTCOME COULD OCCUR."

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CLINICOMP CIS AND FMRD SYSTEM FETAL MONITOR REMOTE DISPLAY HEL CLINICOMP INTL. NI NA

Patients

Seq Age Sex Outcome Treatment
1 NO INFO