BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MRW2515 AND MRW3015

    MDR report key: 12667528 · Received October 20, 2021

    Report

    Report Number
    1067162-2021-00003
    Event Type
    Malfunction
    Date Received
    October 20, 2021
    Date of Event
    September 21, 2021
    Report Date
    October 19, 2021
    Product Code
    GXY
    UDI-DI
    10816312024439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    RHYTHMLINK INTERNATIONAL, LLC OPENED AN INVESTIGATION TO ASCERTAIN THE ROOT CAUSE OF THE EVENT, AND SUBSEQUENTLY REVIEWED PRODUCTION RECORDS. NO NON-CONFORMANCES WERE IDENTIFIED. THE CUSTOMER DID NOT RETURN THE DEFECTIVE PRODUCT FOR REVIEW. THE INVESTIGATION IS ONGOING, AND THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    RHYTHMLINK INTERNATIONAL, LLC RECEIVED NOTIFICATION FROM A CUSTOMER THAT THE HEAT SHRINK APPLIED TO THE CABLE ASSEMBLY OF AN INDIVIDUAL MR CONDITIONAL LEAD WIRE WAS SLIPPING OFF OF THE MALE DIN CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567694 MRW2515 AND MRW3015 MR CONDITIONAL WEBB ELECTRODES GXY MRW2515 AND MRW3015 PM00017365 AND PM00017366 10816312024439

    Patients

    Seq Age Sex Outcome Treatment
    1