CONTRACT EQ MM-HSCRIBE-DICOM MIDDLEWARE

Additional Manufacturer Narrative

UPON INSPECTION, THE TECHNICIAN WAS UNABLE TO FIND ANY MALFUNCTION WITH THE DEVICE. THE CAUSE OF THE REPORTED ISSUE WAS DETERMINED TO BE USE ERROR WHERE THE CUSTOMER CHOSE THE WRONG PATIENT FROM THE WORK-LIST. THE SYSTEM CORRECTLY PRESENTED A LIST OF PATIENTS, AND IT APPEARS THE USER SELECTED THE WRONG PATIENT FROM THAT LIST. THE HSCRIBE SYSTEM IS INDICATED FOR USE IN A CLINICAL SETTING, BY QUALIFIED MEDICAL PROFESSIONALS ONLY, FOR PATIENTS REQUIRING AMBULATORY (HOLTER) MONITORING OF 24-48 HOURS. SUCH MONITORING IS MOST FREQUENTLY USED FOR THE PURPOSE OF PROSPECTIVE AND RETROSPECTIVE CARDIAC DATA AND ARRHYTHMIA ANALYSIS. THE ANALYSIS SOFTWARE PACKAGE INCLUDES, AMONG OTHERS, DETECTION AND REPORTING FEATURES APPROPRIATE TO THE INDICATIONS BELOW: EVALUATION OF ADULT PATIENTS WITH SYMPTOMS RELATED TO RHYTHM DISTURBANCES OR SYMPTOMS SUGGESTING ARRHYTHMIA . EVALUATION OF ADULT PATIENTS FOR ST SEGMENT CHANGES . EVALUATION OF ADULT PATIENTS WITH PACEMAKERS . REPORTING OF TIME DOMAIN HEART RATE VARIABILITY . EVALUATION OF INFANT PATIENTS LIMITED TO QRS DETECTION ONLY. THE BAXTER SERVICE THOROUGHLY INSPECTED THE DEVICE AND WAS UNABLE TO DUPLICATE THE REPORTED ISSUE. THE DEVICE FUNCTIONED AS DESIGNED. HOWEVER, IF THE REPORTED EVENT OF AN INCORRECT PATIENT INFORMATION RECORD WERE TO RECUR, IT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY, THEREFORE BAXTER CONSIDERS THIS EVENT REPORTABLE.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY HAD A PATIENT APPEARING TWICE IN HSCRIBE WITH EXACTLY THE SAME NAME, NHS NUMBER, DATE OF BIRTH, AND SETUP TIMESTAMP (SAME DAY, HOUR, MINUTE, AND SECOND). HOWEVER, WHEN OPENING EACH RECORD, THE ECG TRACES WERE COMPLETELY DIFFERENT AND CLEARLY CORRESPOND TO TWO DIFFERENT PATIENTS. THERE WAS NO ADVERSE EVENT REPORTED.