BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITHINGS

    MDR report key: 20489066 · Received October 19, 2024

    Report

    Report Number
    3011420269-2024-00096
    Event Type
    Malfunction
    Date Received
    October 19, 2024
    Date of Event
    June 29, 2023
    Report Date
    June 29, 2023
    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

    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 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 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: HELLO, MY WIFE IS AT HIGH RISK FOR PRE-ECLAMPSIA WE PURCHASED A WITHINGS CONNECT BLOOD PRESSURE MONITOR.THE DEVICE IS WIDELY COMPLAINED ABOUT ONLINE BY CONSUMERS TO GIVE INACCURATE HIGH BLOOD PRESSURE READINGS.WE WERE NOT AWARE OF THIS WHEN WE PURCHASED IT.WE SENT MULTIPLE VIDEOS TO WITHINGS SUPPORT CONFIRMING THE INACCURATE READINGS, HOWEVER THEY REFUSE TO ADMIT IT IS FAULTY.MY WIFE WAS TOLD BY HER DOCTOR SEVERAL TIMES TO GO TO THE ER DURING PREGNANCY TO CHECK FOR PREECLAMPSIA DUE TO THE FAULTY READINGS OF THIS DEVICE.SHE'S BEEN UNDER STRESS DUE TO THIS DEVICE MAKING HER BELIEVE SHE COULD HAVE PREECLAMPSIA AGAIN.WITHINGS NEEDS TO HAVE THIS DEVICE RECALLED AND FDA APPROVAL NEEDS TO BE REVOKED.ACTUAL BLOOD PRESSURE WAS 120/80 (ER(EMERGENCY ROOM)) DEVICE IS REPORTING 160/100.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930580 WITHINGS BLOOD PRESSURE MONITOR DXN GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female