BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARE TOUCH DIGITAL

    MDR report key: 20489073 · Received October 19, 2024

    Report

    Report Number
    3011420269-2024-00098
    Event Type
    Malfunction
    Date Received
    October 19, 2024
    Date of Event
    July 16, 2024
    Report Date
    July 30, 2024
    Manufacturer
    GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
    Product Code
    DXN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CAUSE: WITHOUT A SPECIFIC MODEL AND DEFECTIVE DEVICE, IT IS CHALLENGING FOR TRANSTEK TO CONDUCT A DETAILED ANALYSIS. THERE ARE SOME SIMILAR DEVICE FAILURES FROM OTHER FEEDBACK 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 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

    EVENT DESCRIPTION THE BLOOD PRESSURE MONITOR IS NOT ACCURATE AT ALL. IT'S NOT APPROVED BY FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1931559 CARE TOUCH DIGITAL BLOOD PRESSURE MONITOR DXN GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization