BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUINTON Q-TEL RMS

    MDR report key: 6935922 · Received October 10, 2017

    Report

    Report Number
    MW5072668
    Event Type
    Malfunction
    Date Received
    October 10, 2017
    Date of Event
    October 4, 2017
    Report Date
    October 5, 2017
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    MHX
    UDI-DI
    00312345029604
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DURING A MONITORED CARDIAC REHABILITATION EXERCISE SESSION, OUR G-TEL RMS ECG MONITORING SYSTEM CRASHED. FIVE PTS WERE ON MONITORS AT THE TIME OF THE CRASH. THE SYSTEM DID NOT AUTOMATICALLY REBOOT, AND IT DID NOT RECOVER SESSION DATA. THE SYSTEM HAD TO BE MANUALLY RESTARTED, AND EACH PT INDIVIDUALLY RE-ADMITTED. ALL OF THE DATA FOR EACH PT'S SESSION UP TO THE TIME OF THE CRASH WAS LOST. ECG DATA, BLOOD PRESSURES, RPE, SPO2, AND EXERCISE MODALITIES AND WORKLOADS WERE LOST. THIS PRESENTS A SERIOUS ISSUE AS CARDIAC EVENTS COULD HAVE GONE UNDETECTED DURING THE TIME THE SYSTEM WAS BEING RESTARTED AND THE PTS WERE BEING RE-ADMITTED. ADDITIONALLY, ANY SIGNIFICANT EVENTS THAT OCCURRED DURING THE SESSION PRIOR TO THE CRASH CANNOT BE DOCUMENTED AND RELAYED TO THE CARDIOLOGIST. THE COMPANY HAS BEEN NOTIFIED OF THIS EVENT, AND THEY STATED THAT THEY HAVE BEEN AWARE OF THEIR SYSTEM CRASHING FOR "A FEW MONTHS NOW" AND THAT THEY ARE "WORKING ON A SOLUTION." OUR DEPARTMENT WAS NOT NOTIFIED OF THE ISSUE PRIOR TO YESTERDAY'S OCCURRENCE, AND WE WERE UNAWARE THAT THE SYSTEM WE ARE UTILIZING HAS HAD THIS KNOWN DEFECT. THIS DEFECT SIGNIFICANTLY AFFECTS PT CARE IN A NEGATIVE MANNER AND CAN POTENTIALLY LEAD TO SERIOUS CARDIAC EVENTS GOING UNDETECTED.

    Description of Event or Problem · 2

    DURING A MONITORED CARDIAC REHABILITATION EXERCISE SESSION, OUR G-TEL RMS ECG MONITORING SYSTEM CRASHED. FIVE PTS WERE ON MONITORS AT THE TIME OF THE CRASH. THE SYSTEM DID NOT AUTOMATICALLY REBOOT, AND IT DID NOT RECOVER SESSION DATA. THE SYSTEM HAD TO BE MANUALLY RESTARTED, AND EACH PT INDIVIDUALLY RE-ADMITTED. ALL OF THE DATA FOR EACH PT'S SESSION UP TO THE TIME OF THE CRASH WAS LOST. ECG DATA, BLOOD PRESSURES, RPE, SPO2, AND EXERCISE MODALITIES AND WORKLOADS WERE LOST. THIS PRESENTS A SERIOUS ISSUE AS CARDIAC EVENTS COULD HAVE GONE UNDETECTED DURING THE TIME THE SYSTEM WAS BEING RESTARTED AND THE PTS WERE BEING RE-ADMITTED. ADDITIONALLY, ANY SIGNIFICANT EVENTS THAT OCCURRED DURING THE SESSION PRIOR TO THE CRASH CANNOT BE DOCUMENTED AND RELAYED TO THE CARDIOLOGIST. THE COMPANY HAS BEEN NOTIFIED OF THIS EVENT, AND THEY STATED THAT THEY HAVE BEEN AWARE OF THEIR SYSTEM CRASHING FOR "A FEW MONTHS NOW" AND THAT THEY ARE "WORKING ON A SOLUTION." OUR DEPARTMENT WAS NOT NOTIFIED OF THE ISSUE PRIOR TO YESTERDAY'S OCCURRENCE, AND WE WERE UNAWARE THAT THE SYSTEM WE ARE UTILIZING HAS HAD THIS KNOWN DEFECT. THIS DEFECT SIGNIFICANTLY AFFECTS PT CARE IN A NEGATIVE MANNER AND CAN POTENTIALLY LEAD TO SERIOUS CARDIAC EVENTS GOING UNDETECTED.

    Description of Event or Problem · 3

    DURING A MONITORED CARDIAC REHABILITATION EXERCISE SESSION, OUR G-TEL RMS ECG MONITORING SYSTEM CRASHED. FIVE PTS WERE ON MONITORS AT THE TIME OF THE CRASH. THE SYSTEM DID NOT AUTOMATICALLY REBOOT, AND IT DID NOT RECOVER SESSION DATA. THE SYSTEM HAD TO BE MANUALLY RESTARTED, AND EACH PT INDIVIDUALLY RE-ADMITTED. ALL OF THE DATA FOR EACH PT'S SESSION UP TO THE TIME OF THE CRASH WAS LOST. ECG DATA, BLOOD PRESSURES, RPE, SPO2, AND EXERCISE MODALITIES AND WORKLOADS WERE LOST. THIS PRESENTS A SERIOUS ISSUE AS CARDIAC EVENTS COULD HAVE GONE UNDETECTED DURING THE TIME THE SYSTEM WAS BEING RESTARTED AND THE PTS WERE BEING RE-ADMITTED. ADDITIONALLY, ANY SIGNIFICANT EVENTS THAT OCCURRED DURING THE SESSION PRIOR TO THE CRASH CANNOT BE DOCUMENTED AND RELAYED TO THE CARDIOLOGIST. THE COMPANY HAS BEEN NOTIFIED OF THIS EVENT, AND THEY STATED THAT THEY HAVE BEEN AWARE OF THEIR SYSTEM CRASHING FOR "A FEW MONTHS NOW" AND THAT THEY ARE "WORKING ON A SOLUTION." OUR DEPARTMENT WAS NOT NOTIFIED OF THE ISSUE PRIOR TO YESTERDAY'S OCCURRENCE, AND WE WERE UNAWARE THAT THE SYSTEM WE ARE UTILIZING HAS HAD THIS KNOWN DEFECT. THIS DEFECT SIGNIFICANTLY AFFECTS PT CARE IN A NEGATIVE MANNER AND CAN POTENTIALLY LEAD TO SERIOUS CARDIAC EVENTS GOING UNDETECTED.

    Description of Event or Problem · 4

    DURING A MONITORED CARDIAC REHABILITATION EXERCISE SESSION, OUR G-TEL RMS ECG MONITORING SYSTEM CRASHED. FIVE PTS WERE ON MONITORS AT THE TIME OF THE CRASH. THE SYSTEM DID NOT AUTOMATICALLY REBOOT, AND IT DID NOT RECOVER SESSION DATA. THE SYSTEM HAD TO BE MANUALLY RESTARTED, AND EACH PT INDIVIDUALLY RE-ADMITTED. ALL OF THE DATA FOR EACH PT'S SESSION UP TO THE TIME OF THE CRASH WAS LOST. ECG DATA, BLOOD PRESSURES, RPE, SPO2, AND EXERCISE MODALITIES AND WORKLOADS WERE LOST. THIS PRESENTS A SERIOUS ISSUE AS CARDIAC EVENTS COULD HAVE GONE UNDETECTED DURING THE TIME THE SYSTEM WAS BEING RESTARTED AND THE PTS WERE BEING RE-ADMITTED. ADDITIONALLY, ANY SIGNIFICANT EVENTS THAT OCCURRED DURING THE SESSION PRIOR TO THE CRASH CANNOT BE DOCUMENTED AND RELAYED TO THE CARDIOLOGIST. THE COMPANY HAS BEEN NOTIFIED OF THIS EVENT, AND THEY STATED THAT THEY HAVE BEEN AWARE OF THEIR SYSTEM CRASHING FOR "A FEW MONTHS NOW" AND THAT THEY ARE "WORKING ON A SOLUTION." OUR DEPARTMENT WAS NOT NOTIFIED OF THE ISSUE PRIOR TO YESTERDAY'S OCCURRENCE, AND WE WERE UNAWARE THAT THE SYSTEM WE ARE UTILIZING HAS HAD THIS KNOWN DEFECT. THIS DEFECT SIGNIFICANTLY AFFECTS PT CARE IN A NEGATIVE MANNER AND CAN POTENTIALLY LEAD TO SERIOUS CARDIAC EVENTS GOING UNDETECTED.

    Description of Event or Problem · 5

    DURING A MONITORED CARDIAC REHABILITATION EXERCISE SESSION, OUR G-TEL RMS ECG MONITORING SYSTEM CRASHED. FIVE PTS WERE ON MONITORS AT THE TIME OF THE CRASH. THE SYSTEM DID NOT AUTOMATICALLY REBOOT, AND IT DID NOT RECOVER SESSION DATA. THE SYSTEM HAD TO BE MANUALLY RESTARTED, AND EACH PT INDIVIDUALLY RE-ADMITTED. ALL OF THE DATA FOR EACH PT'S SESSION UP TO THE TIME OF THE CRASH WAS LOST. ECG DATA, BLOOD PRESSURES, RPE, SPO2, AND EXERCISE MODALITIES AND WORKLOADS WERE LOST. THIS PRESENTS A SERIOUS ISSUE AS CARDIAC EVENTS COULD HAVE GONE UNDETECTED DURING THE TIME THE SYSTEM WAS BEING RESTARTED AND THE PTS WERE BEING RE-ADMITTED. ADDITIONALLY, ANY SIGNIFICANT EVENTS THAT OCCURRED DURING THE SESSION PRIOR TO THE CRASH CANNOT BE DOCUMENTED AND RELAYED TO THE CARDIOLOGIST. THE COMPANY HAS BEEN NOTIFIED OF THIS EVENT, AND THEY STATED THAT THEY HAVE BEEN AWARE OF THEIR SYSTEM CRASHING FOR "A FEW MONTHS NOW" AND THAT THEY ARE "WORKING ON A SOLUTION." OUR DEPARTMENT WAS NOT NOTIFIED OF THE ISSUE PRIOR TO YESTERDAY'S OCCURRENCE, AND WE WERE UNAWARE THAT THE SYSTEM WE ARE UTILIZING HAS HAD THIS KNOWN DEFECT. THIS DEFECT SIGNIFICANTLY AFFECTS PT CARE IN A NEGATIVE MANNER AND CAN POTENTIALLY LEAD TO SERIOUS CARDIAC EVENTS GOING UNDETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718899 QUINTON Q-TEL RMS CARDIAC REHABILITATION SYSTEM MHX MORTARA INSTRUMENT, INC. VERSION 4.1.0 00312345029604

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other
    2 54 YR Other
    3 86 YR Other
    4 70 YR Other
    5 79 YR Other