BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION

    MDR report key: 4929856 · Received July 21, 2015

    Report

    Report Number
    3015876-2015-00870
    Event Type
    Malfunction
    Date Received
    July 21, 2015
    Date of Event
    June 24, 2015
    Report Date
    June 24, 2015
    Manufacturer
    PHYSIO-CONTROL, INC
    Product Code
    IKD
    PMA / PMN Number
    K895379
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER ADVISED PHYSIO-CONTROL THAT THEY HAVE SINCE DISPOSED OF THE INTERNAL PADDLES ASSEMBLY AND DID NOT DETERMINE THE CAUSE OF THE REPORTED ISSUE. THE PADDLES ASSEMBLY WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR INTERNAL DEFIBRILLATION PADDLES WAS NOT DELIVERING CONSISTENT ENERGY LEVELS. THE CUSTOMER INDICATED THEY DID NOT HAVE ANY ADDITIONAL CLARIFYING DETAILS OF THE REPORTED ISSUE. THERE WAS NO PATIENT USE REPORTED TO HAVE BEEN ASSOCIATED WITH THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473009 HANDLES AND CONNECTOR WITH DISCHARGE CONTROL FOR INTERNAL DEFIBRILLATION CABLE, ELECTRODE IKD PHYSIO-CONTROL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1