BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOCARE2000

    MDR report key: 2652722 · Received March 20, 2011

    Report

    Report Number
    3003681187-2012-00001
    Event Type
    Malfunction
    Date Received
    March 20, 2011
    Report Date
    March 19, 2012
    Manufacturer
    BIONET CO., LTD.
    Product Code
    LOS
    PMA / PMN Number
    K011328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUED MALFUNCTION IS RELATED TO THE COMPUTER-GENERATED INTERPRETATION. WE REVIEWED THE 73 SAMPLE CARDIOGRAMS TO FIGURE OUT THAT MOST OF THE PHYSICIAN'S ASSESSMENTS ARE CORRECT. THE EVALUATION SUMMARY IS ATTACHED TO THIS MDR.

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL IN (B)(6) HEALTH CLINIC IN (B)(6) ISSUED A REPORT THAT THE COMPUTER-GENERATED INTERPRETATIONS OF CARDIOCARE2000 WERE INACCURATE TO THE FDA THROUGH MEDWATCH AS WELL AS ALERTING US DIRECTLY. THE HEALTH PROFESSIONAL SENT US 73 SAMPLES OF CARDIOGRAMS DONE DURING THE PAST YEAR WITH ERRANT READINGS. AFTER REVIEWING ALL THE COPIES, WE FOUND OUT THE RECURRENT ERRANT READINGS HAPPENED ON IDENTIFYING SINUS ARRHYTHMIA, ECTOPIC (NONSINUS) ATRIAL RHYTHMS, PACED RHYTHMS, SINUS BRADYCARDIA, SIGNIFICANT ST/T-WAVE ABNORMALITIES AND LEFT ANTERIOR FASCICULAR BLOCK. WHILE THE COMPUTER GENERATED INTERPRETATIONS ARE INTENDED AS ONLY A GUIDE FOR PHYSICIANS AND ARE MARKED AS "UNCONFIRMED REPORT" WITH A SPOT FOR THE PHYSICIAN TO SIGN INDICATING THAT THE PHYSICIAN HAS CONFIRMED THE READINGS, WE UNDERSTAND THAT THESE INTERPRETATIONS NEED TO BE AS ACCURATE AS POSSIBLE. FOR THIS CUSTOMER, WE HAVE REPLACED THEIR CARDIOCARE 2000 WITH OUR HIGHER END MODEL, THE CARDIOTOUGH 3000, WHICH SHOULD RESOLVE THEIR IMMEDIATE CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOCARE2000 ELECTROCARDIOGRAPH LOS BIONET CO., LTD. CARDIOCARE2000 EI07

    Patients

    Seq Age Sex Outcome Treatment
    1