FDA Adverse Event Malfunction Summary report: N

INTELLIVUE PATIENT INFORMATION CENTER IX

MDR report key: 10104772 · Received June 1, 2020

Report

Report Number
10104772
Event Type
Malfunction
Date Received
June 1, 2020
Date of Event
February 17, 2020
Report Date
April 2, 2020
Manufacturer
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION
Product Code
MSX
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PATIENT WAS ADMITTED IN THE OBSERVATION ROOM AND SEVERAL HOURS LATER, AT APPROX. 1617, THE PATIENT DISAPPEARED FROM THE FLOOR CENTRAL MONITOR. PATIENT WAS ADMITTED BY THE OBS ROOM TECH, AND THEN DISAPPEARED FOR A PERIOD OF ABOUT 30 MINUTES. PATIENT WAS READMITTED BY OBS ROOM TECH AT ABOUT 1647. THIS IS ONE OF SEVERAL SIMILAR INCIDENTS WHERE PATIENTS WERE INADVERTENTLY TRANSFERRED WITHIN THE PHILIPS SYSTEM. ENGINEERING EVALUATION: CLINICIANS TYPICALLY DO NOT DISCHARGE/END CASE AFTER PATIENT TRANSPORT TO ANOTHER UNIT. PHILIPS STORES FULL DISCLOSURE ON A SINGLE DATABASE WHICH IS PATIENT CENTRIC. IN CASES OF PATIENT CONFLICT ¿ DIFFERENT PATIENTS AT THE MONITOR AND THE X3 ¿ THE MONITOR DISPLAYS MULTIPLE QUESTIONS THAT HAVE BEEN DEEMED AS CONFUSING BY CLINICIANS ESPECIALLY WHEN THEY ARE DEALING WITH AN UNSTABLE PATIENT. CHOOSING THE WRONG ANSWER TO THE QUESTION(S) ENDS UP WITH AN INADVERTENT PATIENT TRANSFER WITHIN THE PHILIP SYSTEM. WHEN THE PATIENT IS "INADVERTENTLY TRANSFERRED" SEVERAL SCENARIOS ARE POSSIBLE, MAINLY: A TELEMETRY PATIENT IS "YANKED OFF" THE CENTRAL IN WHICH CASES THE OBSERVATION ROOM IS FLYING BLIND UNTIL THEY REALIZE THEIR PATIENT IS NO LONGER THERE. SINCE FULL DISCLOSURE FOLLOWS THE PATIENT NAME IN THE PHILIPS SYSTEM, VITALS FROM ONE PATIENT PHYSICALLY IN THE ICU FLOW INTO THE FULL DISCLOSURE OF THE PATIENT "INADVERTENTLY TRANSFERRED." IN SOME INSTANCES WE HAVE SEEN A TUG OF WAR BETWEEN ICU AND TELE BOTH REPEATEDLY TRANSFERRING THE PATIENT TO THEIR AREA. THIS IS PARTICULARLY COMMON IN THE PACU, BUT WE HAVE ALSO SEEN IT HAPPEN IN THE ICU. MANUFACTURER RESPONSE FOR CENTRALIZED PATIENT MONITORING SYSTEM, (BRAND NOT PROVIDED) (PER SITE REPORTER). MANUFACTURER HAS PROVIDED ADDITIONAL STAFF TRAINING BUT THIS HAS NOT BEEN EFFECTIVE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
568414 INTELLIVUE PATIENT INFORMATION CENTER IX SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS MSX PHILIPS ELECTRONICS NORTH AMERICA CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 24455 DA