BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    R2 MULTI-FUNCTION DEFIB PAD

    MDR report key: 1070789 · Received July 3, 2008

    Report

    Report Number
    1320208-2008-00091
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    May 6, 2008
    Report Date
    July 2, 2008
    Manufacturer
    AVENT S.A DE R.L DE C.V.
    Product Code
    MLN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED, AND IS BEING EVALUATED BY OUR QUALITY ENGINEER. ONCE AN INVESTIGATION IS COMPLETE, A SUPPLEMENTAL WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "CONNECTOR MANUFACTURED WITH BLUE/WHITE COLOUR CODING WRONG WAY ROUND. NO INJURY AS PT DIDN'T NEED DEFIBRILLATION DURING THE OPERATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R2 MULTI-FUNCTION DEFIB PAD MULTIFUNCTION DEFIB PAD MLN AVENT S.A DE R.L DE C.V. NA 414396

    Patients

    Seq Age Sex Outcome Treatment
    1