BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPER CP 80

    MDR report key: 97068 · Received June 6, 1997

    Report

    Report Number
    97068
    Event Type
    Injury
    Date Received
    June 6, 1997
    Date of Event
    April 16, 1997
    Report Date
    April 29, 1997
    Manufacturer
    PHILIPS SYSTEME MEDEZIN
    Product Code
    IZO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS UNDERGOING ABLATION OF THE AV NODE AND PACEMAKER IMPLANTATION. REPORTEDLY, IT WAS A VERY DIFFICULT CASE AND AT ONE POINT IT WAS DETERMINED THAT RE-POSITIONING OF THE PACER WAS NEEDED. THE PACEMAKER POCKET WAS OPENED AND ALLEGEDLY AT THAT POINT THE FLUOROSCOPY MACHINE FAILED AND THE CASE WAS SIGNIFICANTLY DELAYED. THE USER FACILITY'S CLINICAL ENGINEERING STAFF DETERMINED THAT THE PROBLEM WAS DUE TO A FAULTY RELAY WHICH WAS SUBSEQUENTLY REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPER CP 80 X-RAY GENERATOR IZO PHILIPS SYSTEME MEDEZIN 9874 294 90102 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention