BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELADOC

    MDR report key: 20808374 · Received November 28, 2024

    Report

    Report Number
    3011420-2024-00104
    Event Type
    Malfunction
    Date Received
    November 28, 2024
    Date of Event
    October 22, 2024
    Report Date
    October 30, 2024
    Manufacturer
    GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CAUSE: WITHOUT A SPECIFIC ISSUE DESCRIPTION AND DEFECTIVE DEVICE FOR RETURN, IT IS CHALLENGING FOR TRANSTEK TO CONDUCT A DETAILED ANALYSIS. THERE ARE SOME SIMILAR DEVICE FAILURES FROM OTHER FEEDBACKS AND THE CAUSE ANALYSIS SHOULD BE THE SAME THEORETICALLY AS BELOW. 1. WE CHECKED THE ALL RELATED DHR, INCLUDING MANUFACTURED PROCESS RECORDS, FQC INSPECTION RECORDS, ECT, AND NO ACCURACY ISSUE WAS FOUND. 2. THE PRODUCT HAS PASSED CLINICAL VALIDATION ISO 81060-2:2018. ITS PERFORMANCE MEETS THE REQUIREMENTS. 3. THE INSTRUCTIONS HAVE ALREADY COVERED THE RELEVANT OPERATION. THE CUSTOMER MIGHT NOT READ THE INSTRUCTIONS CAREFULLY. CORRECTIVE ACTION: 1. ESTABLISH A REGULAR COMMUNICATION MECHANISM WITH OUR CUSTOMER. 2. PREPARE A DOCUMENT CONCERNING TROUBLESHOOTING AND ESSENTIAL PRECAUTIONS AS A NOTIFICATION OF REMINDER FOR CUSTOMER PROMOTION TO MINIMIZE THE RISK OF USER MIS-OPERATIONS. 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 TELADOC HEALTH, INC) A REPLACEMENT DEVICE WAS ORDERED FOR THE PATIENT TO RESOLVE THE REPORTED CONCERN. THE PREVIOUS DEVICE WAS REQUESTED BACK FOR INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED, BUT IF IT IS RETURNED AND REVIEWED, AN UPDATE WILL BE MADE TO THIS REPORT. EVENT DESCRIPTION THE PATIENT REPORTED AN ACCURACY CONCERN WITH THEIR TELADOC BLOOD PRESSURE MONITOR. THEY REPORTED THAT THEIR MONITOR WAS COMPARED TO A MANUAL READING AT THE SAME TIME AND THE TELADOC MONITOR WAS 30 POINTS HIGHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618720 TELADOC BLOOD PRESSURE MONITOR DXN GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD HT900

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Prefer Not To Disclose