BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3M RED DOT NEONATAL MONITORING ELECTRODES

    MDR report key: 2083182 · Received April 13, 2011

    Report

    Report Number
    2110898-2011-00040
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 15, 2011
    Manufacturer
    3M HEALTH CARE
    Product Code
    DRX
    PMA / PMN Number
    K902080
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT AVAILABLE/NO PATIENT(S) INVOLVED IN THE COMPLAINT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. ELECTRICAL WIRE.

    Description of Event or Problem · 1

    A 3M RECEIVED INFORMATION FROM A CUSTOMER REPORTING THAT ONE CASE OF 2269T 3M RED DOT NEONATAL MONITORING ELECTRODES WERE NOT ADHERING OR SHOWING A TRACE. REPLACEMENT PRODUCT WAS SENT TO THE DISTRIBUTOR/CUSTOMER. THE AFFECTED ELECTRODES WERE SENT TO 3M AND ANALYZED. TESTING FOUND THAT THE DEFECT WAS ISOLATED TO THE RED WIRES FROM MN WIRE LOT 100827. MN WIRE HAS BEEN CONTACTED AND WILL INVESTIGATE INTERNALLY TO DETERMINE A ROOT CAUSE AND HOW MUCH OF THE LEAD WIRE INVENTORY IS AFFECTED. 3M WILL CONTINUE TO MONITOR FOR THIS DEFECT. CORRECTIVE ACTION HAS BEEN RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M RED DOT NEONATAL MONITORING ELECTRODES 870.2360 ELECTROCARDIOGRAPH ELECTRODE DRX 3M HEALTH CARE NA 2012-08 PL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA