INTELLISPACE PORTAL
Report
- Report Number
- 3003768277-2024-04763
- Event Type
- Malfunction
- Date Received
- August 28, 2024
- Date of Event
- March 20, 2024
- Report Date
- December 12, 2024
- Manufacturer
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Product Code
- LLZ
- UDI-DI
- 00884838093621
- PMA / PMN Number
- K162025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PHILIPS INVESTIGATION IS ON-GOING. PHILIPS WILL PROVIDE ANOTHER REPORT IN 30 DAYS.
DURING ROUTINE ACTIVITIES, THE CUSTOMER IDENTIFIED AN UNUSUALLY HIGH VOLUME FOR THE LEFT VENTRICLE OF A PATIENT WHILE USING THE PHILIPS INTELLISPACE SOFTWARE FOR MEASURING CARDIAC MRI VOLUMES AND FLOWS. ON 02-AUG-2024 AN ESCALATION FROM THE COMPETENT AUTHORITIES WAS RECEIVED BY PHILIPS (B)(4). THERE WAS NO HARM REPORTED TO THE PATIENT. THE RECORD (B)(4) FINLAND USER REPORT - (B)(4) WAS REVIEWED, AND IT WAS CONFIRMED THAT THE SOFTWARE CURRENTLY BEING INVESTIGATED IS THE MR CARDIAC ANALYSIS WITHIN INTELLISPACE PORTAL (SOFTWARE VERSION 12.1.8) AT (B)(6) HOSPITAL. SUMMARIZED SEQUENCE OF EVENTS AS CONFIRMED IN A MEETING WITH THE CUSTOMER ON 16-OCT-2024: CARDIAC CINE MR DATA IS LOADED IN CMR APPLICATION FOR FUNCTION ANALYSIS. FOR SEGMENTATION, THE ¿AUTOMATIC SEGMENTATION¿ ALGORITHM IS RUN AND THE USER HAS THE AUTOMATICALLY GENERATED CONTOURS WHICH IS ONE OF THE MANY METHODS TO DELINEATE THE CONTOURS. THE OTHER METHODS ARE SEMI-AUTOMATIC OR MANUAL. CONTOURS ARE GENERATED FOR MYOCARDIUM. NAVIGATED TO THE NEXT STAGE OF RESULTS COMPUTATION AND DISPLAY, WHERE THE VALUES SHOWN FOR VOLUMES WERE LARGE (170 ML), AND MUCH MORE THAN EXPECTED AND ALSO DIFFERENT FROM WHAT SIEMENS¿ SOFTWARE PRODUCED (120ML) BECAUSE THE SEGMENTED CONTOURS WERE WIDER THAN THAT PRODUCED BY THE SIEMENS SOFTWARE. THE RESULTS IN THE TABLE WERE NOT AS ANTICIPATED FOR THE PATIENT. THE CUSTOMER CORRECTED ONLY A FEW CONTOURS, BUT NOT ALL, EVEN THOUGH A POP-UP MESSAGE RECOMMENDS REVIEWING ALL THE RELEVANT CONTOURS. THIS LEAVES OUT THE IMPORTANT CONTOURS THAT ARE USED FOR THE FINAL RESULTS CALCULATIONS. THE PHILIPS CLINICAL TEAM PROVIDED ADDITIONAL WORKFLOW TRAINING TO THE CUSTOMER. THE CUSTOMER CONFIRMED THAT THE VALUES ARE MORE ACCURATE WHEN USING THE WORKFLOWS RECOMMENDED BY THE CLINICAL TEAM. THIS COMPLAINT HAS BEEN DETERMINED TO BE NOT REPORTABLE. THE SYSTEM WORKED AS INTENDED, THE USER IGNORED WARNING MESSAGES DURING THE PROCEDURE.
PHILIPS INVESTIGATION IS ON-GOING. PHILIPS WILL PROVIDE ANOTHER REPORT IN 30 DAYS.
FOLLOWING THE INITIAL REPORT SUBMITTED ON 28-AUG-2024, PHILIPS IS CONTINUING THE INVESTIGATION OF (B)(4). THE CUSTOMER ALLEGES SOFTWARE APPLICATION HAS MEASURED VENTRICULAR VOLUMES THAT ARE INCORRECTLY HIGH: ¿EVENT DATE: 20.3.2024, AT (B)(6) HOSPITAL. DESCRIPTION OF THE INCIDENT: PHILIPS INTELLISENSE CARDIOVASCULAR SOFTWARE FOR MEASURING CARDIAC MRI VOLUMES AND FLOWS. THE SOFTWARE WAS USED TO ANALYSE THE SEVERITY OF AORTIC VALVE LEAKAGE IN A PATIENT WITH AORTIC VALVE DISEASE. THE ANALYSIS RESULTED IN A LEFT VENTRICULAR VOLUME OF 170 ML/M2, WHICH IS THE VOLUME ASSOCIATED WITH A SEVERELY DILATED VENTRICLE. THE AORTIC VALVE LEAK WAS CALCULATED TO BE SEVERE. THE MRI WAS PERFORMED NORMALLY WITH A SIEMENS AVANTO MRI MACHINE, WHICH AUTOMATICALLY CALCULATES VENTRICULAR VOLUME AND CONTRACTILE FORCE WITH ITS OWN ALGORITHM. THE VOLUME WAS 120 ML/M2, WHICH IS A VOLUME SUITABLE FOR A MILDLY DILATED VENTRICLE. THE DECISION TO PERFORM AORTIC VALVE SURGERY IS SIGNIFICANTLY INFLUENCED BY THE DEGREE OF DILATATION OF THE LEFT VENTRICLE OF THE HEART, AND THE FINDING OF A SEVERELY DILATED VENTRICLE STRONGLY SUPPORTS THE DECISION TO OPERATE IN AN ASYMPTOMATIC PATIENT. IN CONTRAST, A PATIENT WITH A MILDLY DILATED VENTRICLE IS USUALLY FOLLOWED UP. CONSIDERING THAT IN THE PAST IT IS THE PHILIPS ANALYSIS SOFTWARE THAT HAS SYSTEMATICALLY MEASURED VOLUMES HIGHER THAN THOSE OF THE OTHER TWO ANALYSIS SOFTWARE AT TAYS, IT IS LIKELY THAT IT IS THE ISCV SOFTWARE THAT HAS MEASURED VENTRICULAR VOLUMES THAT ARE INCORRECTLY HIGH.¿ THE RECORD (B)(6) USER REPORT (B)(4) WAS REVIEWED, AND IT WAS CONFIRMED THAT THE SOFTWARE CURRENTLY BEING INVESTIGATED IS THE MR CARDIAC ANALYSIS WITHIN INTELLISPACE PORTAL (SOFTWARE VERSION 12.1.8) AT (B)(6) HOSPITAL ((B)(6)). THE CUSTOMER ALSO INDICATED THAT THE DECISION TO PERFORM SURGERY WAS BASED ON THE RESULTS OF THE INTELLISPACE PORTAL (SEVERELY DILATED VENTRICLE, SEVERE AORTIC VALVE LEAK) AS WELL AS THE PATIENT'S OVERALL CLINICAL CONDITION. OVERALL CLINICAL CONDITION INCLUDED MRI RESULTS SHOWING ASCENDING AORTIC DILATATION AND OLD DISSECTION FLAP IN THE DESCENDING AORTA, AND THE PATIENT ¿HAD SOME EXTRA SYSTOLE.¿ THE SURGICAL/OPERATIVE NOTES WERE UNAVAILABLE, THEREFORE THE OBSERVED DEGREE OF AORTIC REGURGITATION AND LEFT VENTRICULAR DILATION, AND WHETHER THE OBSERVATIONS ALIGN WITH THE REPORTED INTELLISPACE PORTAL RESULTS REMAINS UNKNOWN. HOWEVER, THE CUSTOMER CONFIRMS THAT IN RETROSPECT OF THE EVENT, THE PATIENT HAD OTHER CLINICAL SIGNS THAT INDICATED SURGICAL INTERVENTION WAS NECESSARY, HENCE THE INTELLISPACE PORTAL RESULTS ARE NOT ASSOCIATED WITH UNNECESSARY MEDICAL INTERVENTION IN THIS CASE. AFTER THE SURGERY, THE PATIENT EXPERIENCED SOME POSTOPERATIVE PERICARDIAL EFFUSION WHICH REQUIRED OUTPATIENT VISITS, BUT HE IS RECOVERING AND HAS RETURNED TO NORMAL DAILY FUNCTIONS. THEREFORE, BASED ON THE CUSTOMER¿S RECENT RESPONSE AND AVAILABLE INFORMATION, THE PATIENT¿S CARDIAC CONDITION AND SUBSEQUENT SURGERY IS CONSIDERED THEIR PRE-EXISTING CONDITION AND MEDICALLY NECESSARY TREATMENT AS DETERMINED BY THEIR PHYSICIAN; THERE IS NO ACTUAL INJURY AND THUS THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO AN INJURY IN THIS CASE. PHILIPS INVESTIGATION INTO THIS ISSUE IS ONGOING, PLANNED NEXT STEPS INCLUDE: FURTHER CONVERSATIONS WITH THE CUSTOMER TO MAP THEIR EXACT WORKFLOW WHEN ENCOUNTERING THIS ISSUE. TO PERFORM FURTHER TESTING TO DETERMINE IF THIS BEHAVIOR IS THE SYSTEM WORKING AS DESIGNED OR A DEFECT IN THE SOFTWARE AND/OR LABELLING. PHILIPS WILL PROVIDE ANOTHER REPORT IN 30 DAYS.
IT HAS BEEN REPORTED TO PHILIPS BY THE FINNISH MEDICINES AGENCY (REFERENCE FIMEA-V163069), THAT ONE OF PHILIPS APPLICATIONS, USED IN TAYS SYDÄNSAIRAALA HOSPITAL, WHICH MEASURES LEFT VENTRICULAR VOLUME, GIVES DIFFERENT RESULTS THAN OTHER VENDORS GIVE FOR THE SAME DATA. AS DESCRIBED, IF THE RESULTS WE GIVE ARE SIGNIFICANTLY WRONG, IT MAY RESULT IN UNNECESSARY INTERVENTIONAL TREATMENT. THERE IS NO ALLEGATION OF PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.
IT HAS BEEN REPORTED TO PHILIPS BY THE FINNISH MEDICINES AGENCY (REFERENCE (B)(4)), THAT ONE OF PHILIPS APPLICATIONS, USED IN TAYS SYDÄNSAIRAALA HOSPITAL, WHICH MEASURES LEFT VENTRICULAR VOLUME, GIVES DIFFERENT RESULTS THAN OTHER VENDORS GIVE FOR THE SAME DATA. AS DESCRIBED, IF THE RESULTS WE GIVE ARE SIGNIFICANTLY WRONG, IT MAY RESULT IN UNNECESSARY INTERVENTIONAL TREATMENT. THERE IS NO ALLEGATION OF PATIENT OR USER HARM. DURING ROUTINE ACTIVITIES, THE CUSTOMER IDENTIFIED AN UNUSUALLY HIGH VOLUME FOR THE LEFT VENTRICLE OF A PATIENT WHILE USING THE PHILIPS INTELLISPACE SOFTWARE FOR MEASURING CARDIAC MRI VOLUMES AND FLOWS. ON 02-AUG-2024 AN ESCALATION FROM THE COMPETENT AUTHORITIES WAS RECEIVED BY PHILIPS (FIMEA-V163069). THERE WAS NO HARM REPORTED TO THE PATIENT. THE RECORD (B)(4) FINLAND USER REPORT - (B)(4) WAS REVIEWED, AND IT WAS CONFIRMED THAT THE SOFTWARE CURRENTLY BEING INVESTIGATED IS THE MR CARDIAC ANALYSIS WITHIN INTELLISPACE PORTAL (SOFTWARE VERSION 12.1.8) AT TAYS HEART HOSPITAL (TAYS SYDANKESKUS OY). SUMMARIZED SEQUENCE OF EVENTS AS CONFIRMED IN A MEETING WITH THE CUSTOMER ON 16-OCT-2024: CARDIAC CINE MR DATA IS LOADED IN CMR APPLICATION FOR FUNCTION ANALYSIS. FOR SEGMENTATION, THE ¿AUTOMATIC SEGMENTATION¿ ALGORITHM IS RUN AND THE USER HAS THE AUTOMATICALLY GENERATED CONTOURS WHICH IS ONE OF THE MANY METHODS TO DELINEATE THE CONTOURS. THE OTHER METHODS ARE SEMI-AUTOMATIC OR MANUAL. CONTOURS ARE GENERATED FOR MYOCARDIUM. NAVIGATED TO THE NEXT STAGE OF RESULTS COMPUTATION AND DISPLAY, WHERE THE VALUES SHOWN FOR VOLUMES WERE LARGE (170 ML), AND MUCH MORE THAN EXPECTED AND ALSO DIFFERENT FROM WHAT SIEMENS¿ SOFTWARE PRODUCED (120ML) BECAUSE THE SEGMENTED CONTOURS WERE WIDER THAN THAT PRODUCED BY THE SIEMENS SOFTWARE. THE RESULTS IN THE TABLE WERE NOT AS ANTICIPATED FOR THE PATIENT. THE CUSTOMER CORRECTED ONLY A FEW CONTOURS, BUT NOT ALL, EVEN THOUGH A POP-UP MESSAGE RECOMMENDS REVIEWING ALL THE RELEVANT CONTOURS. THIS LEAVES OUT THE IMPORTANT CONTOURS THAT ARE USED FOR THE FINAL RESULTS CALCULATIONS. THE PHILIPS CLINICAL TEAM PROVIDED ADDITIONAL WORKFLOW TRAINING TO THE CUSTOMER. THE CUSTOMER CONFIRMED THAT THE VALUES ARE MORE ACCURATE WHEN USING THE WORKFLOWS RECOMMENDED BY THE CLINICAL TEAM. THIS COMPLAINT HAS BEEN DETERMINED TO BE NOT REPORTABLE. THE SYSTEM WORKED AS INTENDED, THE USER IGNORED WARNING MESSAGES DURING THE PROCEDURE.
IT HAS BEEN REPORTED TO PHILIPS BY THE FINNISH MEDICINES AGENCY (REFERENCE (B)(4)), THAT ONE OF PHILIPS APPLICATIONS, USED IN (B)(6) HOSPITAL, WHICH MEASURES LEFT VENTRICULAR VOLUME, GIVES DIFFERENT RESULTS THAN OTHER VENDORS GIVE FOR THE SAME DATA. AS DESCRIBED, IF THE RESULTS WE GIVE ARE SIGNIFICANTLY WRONG, IT MAY RESULT IN UNNECESSARY INTERVENTIONAL TREATMENT. THERE IS NO ALLEGATION OF PATIENT OR USER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191453 | INTELLISPACE PORTAL | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL | LLZ | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. | INTELLISPACE PORTAL | 00884838093621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |