BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOLOGS HOLTER PLATFORM

    MDR report key: 16752764 · Received April 17, 2023

    Report

    Report Number
    1000341190-2023-00001
    Event Type
    Death
    Date Received
    April 17, 2023
    Date of Event
    March 17, 2023
    Report Date
    October 13, 2025
    Manufacturer
    PHILIPS FRANCE COMMERICAL
    Product Code
    DPS
    PMA / PMN Number
    K212112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER MENTIONED TWO RECORDINGS ((B)(4)) WHERE CARDIOLOGS MISSES VF AND ASYSTOLE IDENTIFICATION IN THE ECG ANALYSIS REPORT. FURTHER RESEARCH WAS PERFORMED TO LOOK INTO HISTORICAL PREVENTICE RECORDINGS TO UNDERSTAND HOW THE DEVICE HAS PERFORMED IN REGARD TO PAUSES TO MAKE THEM MORE COMFORTABLE THAT THESE CASES ARE "NORMAL/EXPECTED" OCCASIONAL MISSES AND NOT A SIGN OF A DEEPER PROBLEM. A 12 MONTH LOOK BACK AT ALL PREVENTICE RECORDINGS (ENCOMPASSING 400K) TO FURTHER ANALYZE THE EFFICACY OF OUR PAUSE DETECTION. OUR DETECTION IS PERFORMING AT OR ABOVE THE LEVELS WE WOULD ALWAYS EXPECT AND BELIEVE THESE CONCERNS TO BE BOTH VALID, BUT WITHIN REASON.

    Additional Manufacturer Narrative · 0

    CUSTOMER REPORTED THAT A PATIENT DIED WHILE UNDER THE USE OF AN ECG RECORDING DEVICE. THE ECG INFORMATION WAS TRANSMITTED TO THE CARDIOLOGS PLATFORM WHICH IS UTILIZED TO ANALYZE THE ECG RECORDING FROM THAT PATIENT. CUSTOMER IS CLAIMING  THE CARDIOLOGS PLATFORM MISSED A PAUSE/VF FROM THE PATIENT'S RECORDING. HOWEVER, INDICATIONS FOR USE OF THE CARDIOLOGS PLATFORM DO NOT CLAIM AN ABILITY TO DETECT VF. CARDIOLOGS HAS REQUESTED ADDITIONAL DETAILS BEHIND THE EVENT TO UNDERSTAND THE CIRCUMSTANCES OF THE USE, THE PATIENT, AND HAVE YET TO HEAR BACK FROM THE CUSTOMER. A FOLLOW UP REPORT WILL BE UPDATED UPON FURTHER INVESTIGATION OF THE INCIDENT

    Additional Manufacturer Narrative · 0

    THE ORIGINAL CASE (B)(4) FROM 2023, REFERENCED TWO DIFFERENT STRIPS. IN REVIEWING THIS COMPLAINT, THE MEDICAL SAFETY MANAGER IDENTIFIED THAT THE FIRST MDR LISTED (1000341190-2023-00001) REFERENCES TWO STRIP IDS IN THE COMPLAINT. DURING THE INVESTIGATION & RE- ANALYSIS INTO THE CASE, THOSE TWO STRIP IDS ARE ASSOCIATED WITH 2 DIFFERENT PATIENTS, SO IT WAS CONCLUDED THAT A SECOND SEPARATE MDR SHOULD HAVE BEEN SUBMITTED AT THE TIME.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT A PATIENT DIED WHILE UNDER THE USE OF AN ECG RECORDING DEVICE. THE ECG INFORMATION WAS TRANSMITTED TO THE CARDIOLOGS PLATFORM WHICH IS UTILIZED TO ANALYZE THE ECG RECORDING FROM THAT PATIENT. CUSTOMER IS CLAIMING  THE CARDIOLOGS PLATFORM MISSED A PAUSE/VF FROM THE PATIENT'S RECORDING.

    Description of Event or Problem · 0

    THE CUSTOMER MENTIONED TWO RECORDINGS WHERE CARDIOLOGS MISSES VENTRICULAR FIBRILLATION (VF) AND ASYSTOLE IDENTIFICATION IN THE ELECTROCARDIOGRAM (ECG) ANALYSIS REPORT. CUSTOMER LATER FOUND OUT THAT PATIENT PASSED AWAY. DATE OF DEATH WAS NOT PROVIDED. ON (B)(6) 2025, THE CASE WAS UPDATED TO DOCUMENT THE FOLLOWING; THE EVENT ASSOCIATED WITH THIS COMPLAINT CASE IS RELATED TO A SINGLE STRIP [ONE3LVED]. THIS MDR 1000341190-2023-00001 WILL BE SEPARATED INTO 3 SEPARATE COMPLAINTS. 2 ADDITIONAL COMPLAINTS WILL BE OPENED TO ADDRESS THE OTHER MISSED EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808065 CARDIOLOGS HOLTER PLATFORM CARDIOLOGS HOLTER PLATFORM DPS PHILIPS FRANCE COMMERICAL 2.3.13

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death