BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WITHINGS

    MDR report key: 20489021 · Received October 19, 2024

    Report

    Report Number
    3011420269-2024-00027
    Event Type
    Malfunction
    Date Received
    October 19, 2024
    Date of Event
    January 13, 2023
    Report Date
    January 18, 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 I HAD BEEN USING A WITHINGS BPM CONNECT BLOOD PRESSURE CUFF. IT WAS READING HIGH WHICH WE DID NOT REALIZE UNTIL I COMPARED IT WITH THE DOCTOR'S OFFICE BLOOD PRESSURE READING. THIS RESULTED IN ME TAKING A BLOOD PRESSURE MEDICATION FOR SEVERAL MONTHS WHEN I DID NOT REQUIRE ONE. OTHER THAN TAKING A MEDICATION I DIDN'T NEED, NO INJURY WAS SUSTAINED. I REPORTED TO WITHINGS AND HAVE HAD SEVERAL EMAILS BACK AND FORTH WITHOUT A SATISFACTORY RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2228498 WITHINGS BLOOD PRESSURE MONITOR DXN GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO. LTD WPM05

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female