FDA Adverse Event Summary report: N

MUSE

MDR report key: 1714081 · Received May 28, 2010

Report

Report Number
1714081
Date Received
May 28, 2010
Date of Event
August 10, 2008
Report Date
May 28, 2010
Manufacturer
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
Product Code
LNX
Report Source
User Facility report
Reporter Location
MA, US
Reporter Occupation
INVALID DATA

Narratives

Description of Event or Problem · 1

PATIENT 12 LEAD ECG RECORDS FOUND BY EDIT LAB STAFF IN THE MUSE UNCONFIRMED REPORT LISTING WITH INACCURATE NAMES ASSIGNED TO RECORDS BY AUTOMATIC PROCESS IN MUSE. -RECORDS TRANSMITTED TO MUSE AS PID: 999999999, NAME: ABSENT. -RECORDS FOUND IN UNCONFIRMED REPORT LISTING AS PID: 999999999, NAME: LASTNAME, FIRSTNAME ISSUE COMMUNICATED TO BIOMED BY THE HOSPITAL'S CARDIO ECG LAB STAFF IN MID 2008. BIOMED LATER INVESTIGATED AND COMPLETED ADDITIONAL TESTING TO CONFIRM THE REPORTED ISSUE. BIOMEDICAL / CLINICAL ENGINEERING: AS HOSPITAL MEDICAL AND INFORMATION TECHNOLOGY INTERFACE AND SHARE DATA, THE INTEGRITY OF EACH SYSTEM'S DATABASE BECOMES INCREASINGLY INTERDEPENDENT. IT IS NECESSARY TO DEVELOP AN UNDERSTANDING OF ALL DATA PROCESSES THAT OCCUR BEFORE, DURING AND FOLLOWING DATA ACQUISITION AND STORAGE IN ORDER TO VERIFY PATIENT RECORD FIDELITY. THIS REPORT DETAILS THE CHARACTERIZATION OF IMPROPER AUTOMATED HOSPITAL INFORMATION SYSTEMS DATA MERGES WITH REGARD TO PATIENT RECORDS IN A GE HEALTHCARE MUSE CLINICAL DATABASE. INITIAL DISCUSSIONS WITH GE: NO CORRECTIONS TO THE NORMALIZATION PROCESS WOULD BE MADE IN VERSION 5 - WILL CONSIDER AS A FEATURE REQUEST FOR VERSION 7. THE PROBLEM IS ONGOING. THE LATEST VERSION (7.1.1) DOES NOT BRING RESOLUTION TO THE ISSUE. GE'S RESPONSE INCLUDED RECOMMENDATIONS FOR PRACTICE CHANGE, BUT DID NOT SPECIFICALLY ADDRESS THE PROBLEM REPORTED IN ANY OF THE NEW VERSIONS (INCLUDING 7). GE HAS DECIDED TO MAKE THE CONCERN A FEATURE REQUEST. GE BASICALLY RECOMMENDED THAT USER ALWAYS ASSIGNS THE PROPER PID AND NAME BEFORE TRANSMISSION TO THE SYSTEM. DO NOT CONFIRM PATIENT RECORDS CONTAINING DEFAULT PID. ANY COMBINATION OF ALPHANUMERIC CHARACTERS WILL BE ACCEPTED AS A VALID PID. DETERMINE IF THERE ARE ANY EXISTING CONFIRMED RECORDS WITH PID SEQUENCES OF ALL 9S OR ANY OTHER DEFAULT PID AS DEFINED BY YOUR INSTITUTION. TO SET DEFAULTS PID SETTINGS FOR YOUR INSTITUTION CREATE A REPORT FOR EACH DEFAULT PID THAT CONTAINS THAT PID # AND ENTER "UNKNOWN PATIENT" OR SIMILAR IN PATIENT NAME FIELD AND CONFIRM THE REPORT. ANY SUBSEQUENT RECORDS WITH A DEFAULT PID AND NO PATIENT NAME WILL NOW HAVE NAME FIELD POPULATED WITH UNKNOWN PATIENT. THIS WILL ALERT USER TO THE FACT THAT RECORD NEEDS TO BE ASSIGNED CORRECT PATIENT DEMOGRAPHICS. NEW LOGIC SHOULD REQUIRE A MINIMUM OF 2 PATIENT IDENTIFIERS FOR ANY MERGE TO TAKE PLACE. ADDITIONAL SAFEGUARDS SHOULD BE IN PLACE AT 12 LEAD CARTS AND BEDSIDE MONITORS THAT OPERATE AS SOURCES OF PATIENT DIAGNOSTIC INFORMATION. THESE SAFEGUARDS SHOULD LIMIT THE POSSIBILITY FOR RECORD EXPORT WITHOUT ADEQUATE PATIENT ID INFORMATION.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MUSE ECG DATA MANAGEMENT DATABASE SYSTEM LNX GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MUSE *

Patients

Seq Age Sex Outcome Treatment
1 *