CONTEC TLC 5000 DYNAMIC ECG SYSTEMS
Report
- Report Number
- MW5118833
- Event Type
- Malfunction
- Date Received
- June 23, 2023
- Date of Event
- April 20, 2023
- Report Date
- June 29, 2023
- Manufacturer
- CONTEC MEDICAL SYSTEMS CO., LTD.
- Product Code
- MLO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- UK
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 7/5/2023 FOR REPORT MW5118833. THIS IS EDITED , SHORTENED REPORT AS THE INITIAL ONE I SENT A HAD TOO MANY WORDS WHICH WERE NOT INCLUDED. THE ACCURACY OF THE DEVICE -GENERATED FINDINGS IS QUESTIONABLE. THERE WERE NUMEROUS ARTIFACTS BUT NO MENTION IN THE REPORT ABOUT OVERALL CONTRIBUTION TO THE REPORT FINDINGS. THERE WERE SEVERAL EXAMPLES OF THE SYSTEMS ANALYSIS SYSTEM SHOWING NO CORRELATION WITH THE RAW DATA. THE ANALYSIS MISSED WHAT APPEARS TO BE SOME NON- CONDUCTED BEATS AND DOES NOT MENTION THEM IN THE REPORT. THERE WAS SOME DISCORDANCE BETWEEN THE INFORMATION AT THE FRONT (SUMMARY) PAGE OF THE REPORT AND THE BODY OF THE REPORT, INCLUDING THE ARRHYTHMIA TABLE AND HRV CHART, MAXIMUM AND MINIMUM HR VALUES, ST SEGMENT. THE 'V RUN' IN THE REPORT AT (10:50:08) DID NOT CORRELATE WITH THE RAW DATA. THE FRONT PAGE OF THE REPORT DOES NOT INCLUDE THE TIMES OF ARRHYTHMIAS, ST SEGMENT DEVIATION OR EXAMPLES OF ECG RHYTHM STRIPS FOR REVIEWER TO CORRELATE WITH FINDINGS (ONLY X2 12-LEAD ECGS, TO SHOW THE MAX AND MINIMUM HR). IT WAS NOT CLEAR WHAT THE LAST ROW OF THE ST TABLE REPRESENTED (LABELLED 'ALL'); FROM CALCULATION I CONCLUDED THIS REPRESENTED THE AVERAGE ST VALUES / 24HRS OF EACH LEAD. QTC INTERVAL IS NOT INCLUDED IN THE REPORT ALTHOUGH THERE IS AN INTERFACE IN THE SYSTEM FOR THE QT INTERVAL, WHICH SHOWED ELEVATED QTC (MAX QTC 689.2 AND MIN QTC 529.6) - WHICH WAS NOT FLAGGED. T WAVE ALTERNAN ANALYSIS (TWA) WAS NOT FUNCTIONAL, SCREEN ONLY SHOWING RAW DATA ON THE RIGHT SIDE WITH ERROR MESSAGE ON THE LEFT SIDE: 'NO TWA'. THE MANUAL DOES NOT SAY WHAT TO DO IF UNAVAILABLE. THE PRODUCT INFORMATION DOES NOT SPECIFY HOW MANY AND WHICH SPECIFIC WAVEFORMS IT CA PICK UP, GIVING ONLY A HANDFUL OF EXAMPLES AND PACEMAKER CONCLUSION: THE OVERALL ACCURACY OF THE SYSTEM' INCLUDING THE REPORT IS QUESTIONABLE, MAKING EXTENSIVE EDITING (AND CROSS CHECKING WITH THE RAW DATA) MANDATORY TO AVOID ERRORS AND RISK TO PATIENTS (MISDIAGNOSIS AND MANAGEMENT). THE SYSTEM IS VERY COMPLEX AND TIME CONSUMING, WITH MANY INTERFACES NOT IMMEDIATELY APPARENT AND THEREFORE TRAINING IS NECESSARY FOR NON-SPECIALISTS (I.E., NON-CARDIAC ELECTROPHYSIOLOGISTS AND CARDIOLOGISTS WITH ECG HOLTER EDITING AND REPORTING EXPERIENCE); NON SPECIALISTS USING THIS SYSTEM MAY BE WORKING BEYOND THEIR SCOPE OF PRACTICE, INCLUDING THOSE WITH EXPERIENCE ONLY INTERPRETING RESTING ECGS. THIS IS NOT MADE VERY CLEAR IN THE PRODUCT INFORMATION, WHICH IS VAGUE, STATING HEALTH CARE PROFESSIONALS, THERAPISTS ETC. THAT CAN USE. BEING FDA CLEARED MAY ELICIT CONFIDENCE IN THE SYSTEM, BYPASSING EDITING AND RAW DATA REVIEW/ CROSS CHECKING AND GOING STRAIGHT TO THE REPORT PAGE. THEREFORE, THERE NEEDS TO BE A REMINDER (OR WARNING) THAT THE 'SPECIALIST 'SHOULD EDIT AND REVIEW THE WHOLE STUDY BEFORE GENERATING THE FINAL REPORT OR ADDING THE CONCLUSION (BY DEFAULT LEFT BLANK ON THE FRONT PAGE OF THE REPORT). I HAVE SEVERAL EXAMPLES AND SCREENSHOTS OF THE ISSUES I FOUND WHICH NEED TO BE E-MAILED AS CANNOT APPEND THE FILES HERE, TOO LARGE. NOTE, I BOUGHT THE DEVICE ONLINE FROM UK, IT SHIPPED FROM CHINA AND I ASKED FOR A RETURN WHICH THE SELLER GAVE USA ADDRESS ALTHOUGH THEY ALSO HAVE AN EU ONLINE STORE. HOWEVER, THE USA ADDRESS LINKS TO CHINESE WEBSITE AND CONTACT DETAILS. THE SELLER/ COMPANY CLEARLY HAVE NO AFTER SALES SUPPORT PROCESSES, IN MY EXPERIENCE WERE BE INDIFFERENT TO ISSUES REPORTED, INCLUDING BURNS FROM THE ELECTRODES; THERE WAS NO INTEREST OR APOLOGY. ALSO, WHEN I HIGHLIGHTED DIFFERENCES BETWEEN THE LEAD I RECEIVED VS THE ONE ADVERTISED, THE SELLER INSISTED THERE WERE NO DIFFERENCES AND I ONLY HAD TO PASTE THE LOOSE WIRES TOGETHER BEFORE USING FOR PATIENTS. I'M NOT SURE THAT THE SELLER / COMPANY KEEPS RECORD ON FOLLOW UP ON REPORTED ISSUES. THIS DEVICE IS FREELY AVAILABLE TO BUY ONLINE INCLUDING TO THE PUBLIC. WHY AFTER SEVERAL YEARS IS THERE STILL SUCH ISSUES WITH THIS DEVICE? I ONLY USED THE PRODUCT ONCE AND FOUND ISSUES . LATER, I NAVIGATED THE ANALYSIS SYSTEM AND CROSS CHECKED A LOT OF THINGS AND SOME OF THE REPORT AND THIS IS WHEN I REALIZED THE EXTENT OF INACCURACIES.
THE SYSTEM GENERATED REPORT. THE LAST TWO PAGES OF THE FORMAL REPORT ONLY SHOW THE 12-LEAD ECG (ELECTROCARDIOGRAM) EXAMPLES OF MINIMUM AND MAXIMUM HEART RATES; THERE ARE NO OTHER ECG REPRESENTATIONS OF OTHER RHYTHM ABNORMALITIES PICKED UP, QTC (CORRECTED QT INTERVAL), STE (ST ELEVATION), STD (INDICATOR OF MYOCARDIAL ISCHEMIA) ETC. ARRHYTHMIA TABLE AND HRV (HEART RATE VARIABILITY) CHART DISCORDANCE. IN THE ARRHYTHMIA TABLE E.G. (TIME: 19:18-20:18), THE MAXIMUM HR (HEART RATE) IS 127 BPM (BEATS PER MINUTE) AND MINIMUM HR 68 BPM. HOWEVER, THE HRV CHART FOR THE CORRESPONDING TIME REPORTS THE MAXIMUM R-R INTERVAL (MS) AS 1560MS AND MINIMUM R-R AS 300MS, WHICH EQUATES TO A MINIMUM HEART RATE OF 38 BPM AND MAXIMUM HR OF 200 BPM, RESPECTIVELY. THERE ARE NO REPORTED BRADYCARDIC EPISODES OR DANGEROUS VENTRICULAR TACHYCARDIAS IN THE REPORT OR FROM THE RAW DATA. ADDITIONALLY, THE HOURLY HRV CHART REPORTS A TOTAL OF 20 HOURS (OUT OF 24 HOURS) WHERE THE MINIMUM R-R INTERVAL HAD BEEN BETWEEN 300-370MS (SUGGESTING I'D HAD A MAXIMUM HEART RATE OF AT LEAST 150 BPM HOURLY FOR 20 HOURS WHICH WAS NOT THE CASE). THE MAXIMUM HEART RATE REPORTED WAS 141 OR 139 (SEE CONTRADICTION BELOW). THE MAXIMUM R-R VALUES IN 24 HOURS WERE REPORTED AS BETWEEN 790-1560MS (= A MAXIMUM HR OF 40-76 BPM OVER 24 HOURS), WHICH DID NOT CORRELATE WITH THE INFORMATION IN OTHER PARTS OF THE REPORT OR THE RAW DATA; FOR EXAMPLE: THE FRONT PAGE OF THE REPORT STATES MY MINIMUM HR AS 54 BPM AND MAXIMUM HR AS 141 BPM WHILST THE ARRHYTHMIA TABLE ON THE FOLLOWING PAGE STATES MY MINIMUM HR AS 58 BPM AND MAXIMUM HR OF 139 BPM. THESE 'MINOR' INCONSISTENCIES COLLECTIVELY ADD TO CONCERNS ABOUT RELIABILITY OF THIS SYSTEM AND FROM EXAMPLES I'VE GIVEN FROM THE RAW DATA. THERE IS NO MENTION OF THE SEVERAL ARTIFACTS AND OVERALL CONTRIBUTION THESE COULD HAVE MADE TO THE FINDINGS. ST SEGMENT TABLE (HOURLY OVER 24 HOURS) ACCURACY QUESTIONABLE. THE FRONT PAGE OF THE REPORT SUGGESTS ST ELEVATION OF 0.2MV/MIN IN LIMB LEADS 111, AVL, V3 AND SEVERAL ST DEPRESSIONS OF 0.1 MV/MIN IN VARIOUS LEADS. THERE IS NO INFORMATION ABOUT THE TIMES THESE OCCURRED. THE VALUES IN THE ST TABLE (HOURLY VALUES OVER 24 HOURS) IN THE BODY OF THE REPORT DO NOT CORRELATE WITH THE INFORMATION ON THE FRONT PAGE OF THE REPORT (E.G., THE FRONT PAGE OF THE REPORT HAS SET ST VALUES OF 0.1 AND 0.2, FOR DEPRESSION AND ELEVATION, RESPECTIVELY). HOWEVER, THE TABLE PAGE SHOWS ST VALUES OF LESS THAN THE ABOVE, WITH MAXIMUM ST VALUE BEING 0.09MV (LEAD V2 COLUMN) AND MINIMUM ST VALUES OF -0.01, -0.00 AND 0.00 IN SEVERAL LEADS IN THE TABLE. SO HOW CAN THE REPORT MARK HIGHER VALUES ON THE FRONT PAGE? ADDITIONALLY, IT IS UNCLEAR WHAT THE LAST ROW OF THE ST TABLE IS SUPPOSED TO REPRESENT AS IT ONLY STATES 'ALL' FOLLOWED BY COLUMNS OF ST VALUES FOR EACH LEAD. ONLY WHEN I CALCULATED THE AVERAGE ST VALUE USING LEAD V2 COLUMN WHICH CAME UP TO 0.0696 (PRESUMABLY ROUNDED OFF TO 0.07 IN THE TABLE) COULD I ASSUME THE LAST ROW ('ALL) REPRESENTED THE AVERAGE ST VALUES OVER 24 HOURS FOR EACH LEAD. HOWEVER, THE ACCURACY OF THESE VALUES IS QUESTIONABLE GIVEN THE NUMBER OF ARTIFACTS AND IN THE ABSENCE OF A SPECIALIST MANUALLY REVIEWING AND EDITING THIS STUDY. QTC INTERVALS RAISED NOT INCLUDED IN THE REPORT OR FLAGGED. ACCURACY QUESTIONABLE. THERE IS NO QTC INTERVAL MENTIONED IN THE REPORT ALTHOUGH THIS APPEARS AS PART OF THE ANALYSIS SOFTWARE. QTC INTERFACE IS INCLUDED BY THE SYSTEM. THE EXAMPLES ON THE SYSTEM SELECTED QT INTERVALS INCLUDED ARTIFACTS AND T-WAVES THAT WERE ALMOST FLAT. IT WAS IMPOSSIBLE TO KNOW WHERE THE T-WAVE STARTED OR ENDED. AS ANALYZED BY THE SYSTEM, THE QTC INTERVALS WERE CONSISTENTLY ELEVATED, EG, MAXIMUM QTC 689.2 AND MINIMUM QTC 529.6. THERE WERE NO FLAGS TO ALERT USER OF ABNORMALITY. V RUN TABLE IN REPORT, ACCURACY QUESTIONABLE. THE AUTOMATED REPORT HAS A PAGE TITLED 'V RUN TABLE' WHICH REPORTS ONE EPISODE OF V RUN STARTING AT (10:50:08), LENGTH 1335MS WITH AVERAGE HR OF 134 BPM, 3 BEATS. HOWEVER, ON CHECKING, I FOUND NO RAW DATA FOR THE SAME TIME (10:50:08), INSTEAD THERE WAS TIME 10:50:09 AND 10:50:07, WHICH SHOWED A LOT OF NOISE THEREFORE RELIABILITY OF THE 'V RUN. THE IMPRESSION I HAVE BEEN LEFT WITH IS THAT THE USE OF THIS DEVICE SHOULD BE RESTRICTED TO APPROPRIATELY TRAINED MEDICAL PERSONNEL OR SPECIALISTS SUCH AS CARDIAC ELECTROPHYSIOLOGISTS AND CARDIOLOGISTS WITH EXPERIENCE IN HOLTER EDITING AND REPORTING. THE NUMBER OF ARTIFACTS ALSO MAKE IT DIFFICULT FOR THE NON-SPECIALIST TO RELIABLY REVIEW AND EDIT THE RAW DATA. THE COMPLEXITY OF THE SOFTWARE OF THIS SYSTEM BECAME APPARENT WITH CONTINUED EXPOSURE AND IT CLEARLY REQUIRES A LOT OF MANUAL INPUT AND EDITING, COMPLICATED BY AN UNACCEPTABLE NUMBER OF ARTIFACTS. MY VIEW IS, TRAINING NEEDS TO BE PROVIDED FOR THE USE OF THIS EXTENSIVE SYSTEM TO REDUCE PATIENT RISK. SELLER/ COMPANY/MANUFACTURER: I FOUND INDIFFERENCE, LIMITED PRODUCT KNOWLEDGE AND SUPPORT FROM THE SELLER/MANUFACTURER OF THE DEVICE WHEN I REPORTED CONCERNS ABOUT THE ARTIFACTS, ELECTRODE BURNS AND THE AI ANALYSIS SYSTEM. THE MANUFACTURER/SELLER/COMPANY DOES NOT APPEAR TO HAVE ANY AFTER-SALES SUPPORT SYSTEMS IN PLACE, INCLUDING TROUBLESHOOTING, REPORTING, MONITORING OR ESCALATING ANY CUSTOMER REPORTED ISSUES. INSTEAD, IT APPEARS THEIR PRIMARY PURPOSE IS SALES, WITH NO RESTRICTIONS OR CHECKS ON WHO CAN BUY (CONTRARY TO THE LISTING INFORMATION). WHEN I RECEIVED A DIFFERENT LEAD (ALTHOUGH COMPATIBLE) TO THE ONE ADVERTISED, THE SELLER INSISTED THE LEADS WERE EXACTLY THE SAME AND ADVISED I ONLY NEEDED TO PASTE THE WIRES TOGETHER BEFORE USING ON PATIENT. THE SELLER HAD OFFERED ME A PARTIAL REFUND ON THE DEVICE ON CONDITION THAT I FIRST LEFT THEM A POSITIVE REVIEW WHICH I REFUSED TO DO. I LIVE IN (B)(6), THE ITEM SHIPPED FROM CHINA BUT RETURNS TO BE SENT TO USA AT AN ADDRESS IN ILLINOIS, WHOSE WEBSITE LINKS TO CHINA. I EXPRESSED CONCERN ABOUT WHO WOULD SIGN FOR THE RETURNED DEVICE IN USA AND WHETHER IT COULD FLAGGED BY FDA ON ENTRY AND WAS ADVISED TO STATE IT WAS AN ECG RECORDER AND THAT FDA WOULD NOT BE PROBLEM. THE ONLINE PAGE FOR THE USA ILLINOIS ADDRESS SHOWED; 20-APR-2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1422067 | CONTEC TLC 5000 DYNAMIC ECG SYSTEMS | ELECTROCARDIOGRAPH, AMBULATORY, WITH ANALYSIS ALGORITHM | MLO | CONTEC MEDICAL SYSTEMS CO., LTD. | TLC5000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | DISOPYRAMIDE| LEFLUNOMIDE | VERAPAMIL |