Description of Event or Problem · 1
FUKUDA DENSHI USA REC'D VERBAL NOTIFICATION IN 03/2002 THAT A POSSIBLE EQUIPMENT RELATED INCIDENT RESULTING IN A DEATH OF A PT BEING MONITORED ON FUKUDA DENSHI TELEMETRY EQUIPMENT, HAD BEEN REPORTED TO THEM, ON THAT DATE, FROM A HOSP. HOSP WAS CONTACTED BY FUKUDA DENSHI USA TECHNICAL AND REGULATORY MGMT THE SAME DAY. THE HOSP RISK MGMT DIR INFORMED THE CO THAT IN 2002 A PT HAD EXPIRED WHILE BEING MONITORED UTILIZING A FUKUDA DENSHI LX-3100 TELEMETRY TRANSMITER AND A FUKUDA DENSHI CENTRAL STATION MONITOR. SHE STATED THAT THE PT, WHO HAD A DNR (DO NOT RESUSCITATE) ORDER, WAS FOUND TO BE EXPIRED BY A WARD NURSE. HOWEVER, THE CLINICIAN AT THE CENTRAL STATION CONTINUED TO NOTE A NORMAL SINUS RHYTHM AND A HEARTBEAT OF 80 TO 85. RISK MGMT ADDITIONALLY STATED THAT A REP FROM FUKUDA DENSHI HAD EVALUATED THE TRANSMITTER AND COULD NOT ISOLATE THE CAUSE OF WHAT SHE DESCRIBED AS A GHOST SIGNAL. SHE WAS INFORMED THAT FUKDUA DENSHI HAD NOT BEEN NOTIFIED OF THE INCIDENT, BY THE HOSP, NOR HAD A CO REP BEEN DISPATCHED TO EVALUATE THE SITUATION. SHE ATTEMPTED TO FORWARD THE CO'S CALL TO THE HOSP TECHNICAL SVS MGR. BUT WAS UNABLE TO LOCATE HIM. ADDITIONALLY THE CO WAS UNABLE TO CONTACT THE HOSP COO AT THAT TIME. REQUEST FOR CALL BACKS WERE MADE, BUT NONE OCCURED ON THAT DAY. ATTEMPTS TO CONTACT REPS OF THE HOSP, WHO WERE AWARE OF THE INCIDENT, WERE UNSUCCESSFULLY MADE TWICE IN 03/2002. FUKUDA DENSHI USA RECORDS STATE THAT (GTY 2) 6 BED TELEMETRY STATIONS WERE INSTALLED IN THE FACILITY IN 1992. SERVICE RECORDS SHOW NO SIMILAR ISSUES NOTED ON THE SYSTEMS. MEDIQ PRN, A RENTAL EQUIPMENT SERVICE, WAS CONTACTED IN 03/2002 AND IT WAS VERIFIED THAT THEY CURRENTLY HAVE (QTY 2) SIX BED AND (QTY 1) 4 BED FUKUDA DENSHI TELEMTRY SYSTEMS INSTALLED AT THE FACILITY. A LIST OF TELEMETRY CHANNELS USED BY THE MEDIQ PRN TRANSMITTERS WAS REQUESTED AND RECEIVED. A REVIEW OF DATA RECEIVED FROM MEDIC, REVEALED MULTIPLE FREQUENCY CONFLICTS WITH THE ORIGINAL INSTALLED FUKUDA DENSHI SYSTEMS. MEDIC WAS INFORMED AND REQUESTED TO REMOVE THE POSSIBLE CONFLICTING TRANSMITTERS. THE HOSP WAS AGAIN CONTACTED 2 DAYS LATER. CONTACT WAS MADE WITH BOTH THE HOSP COO AND THE MGR OF TECHNICAL SERVICES. THE RESULTING CONFERENCE CALL WHICH INCLUDED THE TWO KINDRED PRINCIPLES NOTED ABOVE AND FUKUDA DENSHI USA TECHNICAL AND REGULATORY MGMT RESULTED IN CONFIRMATION WITH STATEMENT OF RISK MGR. ADDITIONALLY IT WAS STATED THAT THE EQUIPMENT HAD EXHIBITED SIGNAL PROBLEMS FOR SOME TIME AND WAS EVALUATED BY EITHER REPS OF THIRD PARTY BIOMED FIRM (NOT ASSOCATED WITH FUKUDA DENSHI USA) OR BY MEDIQ PRN. IT WAS STATED THAT THE TRANSMITTER INVOLVED WITH THE INCIDENT HAD BEEN REMOVED FROM SERVICE, HOWEVER THEY WERE UNSURE IF IT WAS HOSPITAL OWNED EQUIPMENT (ORIGINAL FUKUDA DENSHI INSTALL) OR RENTAL EQUIPMENT. HOSP MGMT ALSO STATED THEY WERE UNAWARE THAT FUKUDA DENSHI HAD NOT BEEN CONTACTED AND STATED THEY BELEIVED THE 3RD PARTY BIOMED FIRM WAS AFFILIATED WITH FUKUDA DENSHI USA. THEY WERE INFORMED TO CONTACT FUKUDA DENSHI USA DIRECTLY WITH ANY EQUIPMENT ISSUE REGARDLESS OF IT BEING ORIGINAL EQUIPMENT OR RENTALS. FUKUDA DENSHI USA HAS DISPATCHED A TECHNICAL REP TO BE ONSITE AT THE FACILITY 4 DAYS LATER AS AGREED TO BY THE HOSP. THIS ISSUE IS NOT CONSIDERED CLOSED BY FUKUDA DENSHI USA. ADD'L INFO WILL BE FORWARDED TO MEDWATCH FOLLOWING THE ONSITE EVAL.