BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVONGO

    MDR report key: 20489046 · Received October 19, 2024

    Report

    Report Number
    3011420269-2024-00069
    Event Type
    Malfunction
    Date Received
    October 19, 2024
    Date of Event
    October 11, 2023
    Report Date
    November 2, 2023
    Manufacturer
    GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
    Product Code
    DDX
    PMA / PMN Number
    K131395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CAUSE: TRANSTEK COULDN'T GET BACK THE DEVICES CONCERNING THE CASE DIRECTLY. THERE ARE SOME SIMILAR DEVICE FAILURES FROM OTHER FEEDBACK AND THE CAUSE ANALYSIS SHOULD BE THE SAME THEORETICALLY AS BELOW. 1. CHECK THE APPEARANCE OF THE DEVICE AND CUFF, THERE IS NO DEFECT FOUND. 2. TAKE A MEASUREMENT AND CHECK THE SOUND OF PUMP, THE RESULT IS NORMAL. 3. TEST THE STATIC PRESSURE TEST: THE DIFFERENCE OF MEASURE DISPLAY VALUE AND STANDARD VALUE IS LESS THAN 3 MMHG, THE PRESSURE VALUE OF EACH POINT IS CONSISTENT WITH THE ACCURACY. 4. TEST AIR LEAKAGE TEST: THE AIR LEAKAGE VALUE IS LESS THAN 6MMHG, THE TEST IS PASSED. IT INDICATES THAT THE FUNCTION OF THE VALVE IS NORMAL. 5. REAL PERSON TEST: DURING MEASUREMENT PROCESS AND NO PAIN FELT. CONCLUSION: THE AIR PUMP AND CUFF IS WORKING FUNCTIONALLY, AND THE DEVICE INFLATION/DEFLATION FUNCTION IS NORMAL DURING THE TESTING. THE ANALYSIS RESULTS HAVE BEEN CONFIRMED AND AGREED BY TELADOC, AND THIS PROBLEM IS RELATED TO USER PERCEPTION. THE BELOW MISOPERATION WILL LEAD TO INFLATION ISSUE WHICH IS INCLUDED IN USER MANUAL. THE CUSTOMER DIDN'T READ THE INSTRUCTIONS CAREFULLY. ACCORDING TO OUR EXPERIENCE, THE CAUSES OF PATIENT DISCOMFORT CAUSED BY INFLATION/DEFLATION ISSUE AS FOLLOWINGS: 1) DURING THE MEASUREMENT PROCESS, IF THE USER HAS BODY OR ARM SHAKING, TALKING, OR THE USER HAS PERIPHERAL VASCULAR DISEASE/ARRHYTHMIA, ETC., IT WILL INTERFERE WITH THE MEASUREMENT PROCESS. IN ORDER TO ACHIEVE A RELIABLE MEASUREMENT, THE INFLATION PRESSURE VALUE OF THE DEVICE WILL BE CONTINUOUSLY INCREASED, AND THE PRESSURE ON THE ARM WILL BE MORE PRONOUNCED. 2) DURING THE MEASUREMENT PROCESS, IF THE USER WEARS THICKER CLOTHING, IT WILL INTERFERE WITH THE MEASUREMENT PROCESS. IN ORDER TO ACHIEVE A RELIABLE MEASUREMENT, THE INFLATION PRESSURE VALUE OF THE DEVICE WILL BE CONTINUOUSLY INCREASED, AND THE PRESSURE ON THE ARM WILL BE MORE PRONOUNCED. 3) THE MEASUREMENT PRINCIPLE OF THE SPHYGMOMANOMETER REQUIRES THAT THE CUFF BLADDER BE INFLATED TO A CERTAIN VALUE HIGHER THAN THE SYSTOLIC BLOOD PRESSURE BEFORE THE MEASUREMENT CAN BE COMPLETED (THE CUFF AIR PRESSURE MUST BE HIGHER THAN THE SYSTOLIC BLOOD PRESSURE BY MORE THAN 30MMHG). IF THE USER HAS HIGH BLOOD PRESSURE (SUCH AS SYSTOLIC BLOOD PRESSURE 180MMHG, THE BLOOD PRESSURE CUFF WILL INFLATE MORE THAN 210MMHG WHEN MEASURING BLOOD PRESSURE), UNDER NORMAL CIRCUMSTANCES, THE PRESSURE FELT BY THE USER'S ARM WILL BE MORE THAN 30MMHG HIGHER THAN HIS/HER OWN SYSTOLIC BLOOD PRESSURE. CORRECTIVE ACTION: 1. ESTABLISH A REGULAR COMMUNICATION MECHANISM WITH CUSTOMERS 2. PREPARING A DOCUMENT CONCERNING TROUBLESHOOTING AND ESSENTIAL PRECAUTIONS AS A NOTIFICATION OF REMINDER FOR CUSTOMER PROMOTION TO MINIMIZE THE RISK OF USER MISOPERATIONS. CONCLUSION: THIS ISSUE WOULD NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, NOT A MDR EVENT.

    Description of Event or Problem · 0

    MANUFACTURER NARRATIVE (PROVIDED BY LIVONGO): THE DEVICE ASSOCIATED WITH THIS INCIDENT WAS NOT RETURNED FOR INVESTIGATION. SHOULD THIS DEVICE BE RETURNED, A SUPPLEMENTAL REPORT WILL BE FILED TO DOCUMENT THE RESULTS OF THE INVESTIGATION. EVENT DESCRIPTION: THE PATIENT REPORTED THAT THEIR CUFF CONTINUED TO INFLATE AND BRUISED THEIR ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2229497 LIVONGO BLOOD PRESSURE MONITOR DDX GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD HT945

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Prefer Not To Disclose