BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITHINGS

    MDR report key: 20489052 · Received October 19, 2024

    Report

    Report Number
    3011420269-2024-00079
    Event Type
    Malfunction
    Date Received
    October 19, 2024
    Date of Event
    December 11, 2023
    Report Date
    December 11, 2023
    Manufacturer
    GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD
    Product Code
    DXN
    PMA / PMN Number
    K131395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CAUSE: 1. TRANSTEK COULDN'T GET THE COMPLAINT DETAILS FROM END USER AND COULDN'T GET BACK THE DEVICE FOR FURTHER ANALYSIS. 2. NO INVENTORY OF THE SAME MODEL IS FOUND. 3. WE CHECKED THE ALL RELATED DHR, INCLUDING MANUFACTURED PROCESS RECORDS, FQC INSPECTION RECORDS, ECT, AND NO ACCURACY ISSUE WAS FOUND. 4. THE PRODUCT HAS PASSED CLINICAL VALIDATION ISO 81060-2:2018. ITS PERFORMANCE MEETS THE REQUIREMENTS. 5. THE INSTRUCTIONS HAVE ALREADY COVERED THE RELEVANT OPERATION. THE CUSTOMER DIDN'T READ THE INSTRUCTIONS CAREFULLY. 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

    EVENT DESCRIPTION WITHIN WPM05 BPM CONNECT BLOOD PRESSURE CUFF CONSISTENTLY REPORTS SYSTOLIC READINGS THAT ARE APPROXIMATELY 20 POINT HIGH AND DIASTOLIC READINGS THAT ARE 10 POINTS HIGH - 10 TO 15% HIGH WHEN COMPARED WITH A READING TAKEN IN A DOCTOR'S OFFICE AND DIRECTLY COMPARING A TRADITIONAL BLOOD PRESSURE TEST WITH THE WITHING CUFF.AN ONLINE SEARCH REVEALS THAT THERE ARE NUMEROUS COMPLAINTS ABOUT THIS DEVICE.NOTABLY THESE COMPLAINTS ALL COMPLAIN OF THE 10 - 15% HIGH READINGS INDICATING A PRODUCT CALIBRATION PROBLEM.A CHAT CONVERSATION ON (B)(6) 2023 BETWEEN 1 AND 2 PM EST RESULTED IN NO RESOLUTION WITH WITHING'S USING TACTICS OF TRY THIS AND TRY THAT.THE BP CUFF IS A SIMPLE CONCEPT AND SHOULD YIELD ACCURATE READINGS WHEN USED IN ACCORDANCE WITH THE USER INSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930566 WITHINGS BLOOD PRESSURE MONITOR DXN GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male